Day Nurse Capsules
- Name:
Day Nurse Capsules
- Company:
GlaxoSmithKline Consumer Healthcare (Ireland) Ltd
- Active Ingredients:
- Legal Category:
Supply through pharmacy only
Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 04/11/19
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GlaxoSmithKline Consumer Healthcare (Ireland) Ltd
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Company Products
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 4 November 2019 SPC
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 4 November 2019 PIL
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 PIL
Reasons for updating
- Change to section 6 - manufacturer
Updated on 25 February 2019 SPC
Reasons for updating
- Change to section 6.1 - List of excipients
Legal category: Supply through pharmacy only
Updated on 19 September 2018 SPC
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 3 September 2018 PIL
Reasons for updating
- Change to section 2 - use in children and adolescents
Updated on 3 September 2018 SPC
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 SPC
Reasons for updating
- New SPC for new product
Legal category: Supply through pharmacy only
Updated on 26 October 2017 SPC
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
Updated on 26 October 2017 PIL
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
Updated on 17 July 2017 SPC
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 4.8 - addition of 'Very rare cases of serious skin reactions have been reported'
Updated on 17 July 2017 PIL
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 4.8 - addition of 'Very rare cases of serious skin reactions have been reported'
Updated on 18 October 2016 SPC
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
Updated on 18 October 2016 PIL
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
Updated on 3 October 2016 PIL
Reasons for updating
- New PIL for new product
Updated on 3 May 2016 PIL
Reasons for updating
- Change to section 7 - Marketing authorisation holder
Free text change information supplied by the pharmaceutical company
Updated on 3 May 2016 SPC
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 on 10 July 2015 PIL
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 SPC
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 SPC
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
Updated on 29 January 2015 PIL
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
Free text change information supplied by the pharmaceutical company
Updated on 11 March 2014 PIL
Reasons for updating
- Change to section 6.1 - List of excipients
Free text change information supplied by the pharmaceutical company
Updated on 11 March 2014 SPC
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
Updated on 22 June 2012 SPC
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
Updated on 22 June 2012 PIL
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
Updated on 1 September 2011 SPC
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 1 September 2011 PIL
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 PIL
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 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 SPC
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 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 SPC
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 PIL
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 9 January 2008 SPC
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
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 9 January 2008 PIL
Reasons for updating
- Change to section 6.1 - List of excipients
Free text change information supplied by the pharmaceutical company
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 SPC
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 PIL
Reasons for updating
- Change to section 6.3 - Shelf life
- Change to section 6.4 - Special precautions for storage
Updated on 4 June 2004 SPC
Reasons for updating
- New SPC for new product
Legal category: Supply through pharmacy only
Updated on 4 June 2004 PIL
Reasons for updating
- New SPC for new product