Benylin Day and Night Tablets
*Company:
KenvueStatus:
No Recent UpdateLegal Category:
Supply through pharmacy onlyActive Ingredient(s):
*Additional information is available within the SPC or upon request to the company
Updated on 19 September 2024
File name
ie-spc V17 clean benylin day and night 2559.pdf
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
Updated on 02 August 2024
File name
ie-pl-benylin-day-and-night-2558.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 4 - possible side effects
- Change to section 6 - date of revision
Updated on 02 August 2024
File name
ie-spc-v16-benylin-day-and-night -2558.pdf
Reasons for updating
- Change to section 4.3 - Contraindications
- 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 01 August 2024
File name
ie-pl-benylin-day-and-night-2547.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 4 - possible side effects
- Change to section 6 - date of revision
Updated on 01 August 2024
File name
ie-spc-v15-benylin-day-and-night-2547.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 4.8 - Undesirable effects
- Change to section 10 - Date of revision of the text
Legal category:Supply through pharmacy only
Updated on 29 April 2024
File name
ie-pil-benylin-day&night-tabs-2441.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 29 April 2024
File name
ie-spc v14 benylin day and night-2441.pdf
Reasons for updating
- Change to section 7 - Marketing authorisation holder
- Change to section 8 - Marketing authorisation number(s)
- Change to section 10 - Date of revision of the text
Legal category:Supply through pharmacy only
Updated on 31 January 2024
File name
ie-pl-benylin-day-and-night 2430.pdf
Reasons for updating
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 6 - date of revision
Updated on 31 January 2024
File name
ie-spc-v13-benylin-day-and-night-2430.pdf
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- 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 25 April 2023
File name
ie-pil- benylin day & night 2252.pdf
Reasons for updating
- Change to section 2 - what you need to know - contraindications
Updated on 25 April 2023
File name
ie-spc V12 benylin day and night 2252.pdf
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:Supply through pharmacy only
Updated on 12 December 2022
File name
ie-pil-benylin day & night-2298.pdf
Reasons for updating
- Change to section 6 - marketing authorisation holder
- Change to section 6 - date of revision
Updated on 02 December 2021
File name
ie-pil-benylin day & night-2132.pdf
Reasons for updating
- Change to section 3 - how to take/use
- Change to section 6 - what the product looks like and pack contents
- Change to section 6 - date of revision
Updated on 02 December 2021
File name
ie-spc V11 benylin day and night-2132.pdf
Reasons for updating
- Change to section 4.3 - Contraindications
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 6.5 - Nature and contents of container
- Change to section 10 - Date of revision of the text
Legal category:Supply through pharmacy only
Updated on 16 December 2020
File name
ie-spc-clean-2090&2107.pdf
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 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 4.7 - Effects on ability to drive and use machines
- Change to section 4.8 - Undesirable effects
- Change to Section 4.8 – Undesirable effects - how to report a side effect
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 5.2 - Pharmacokinetic properties
- Change to section 5.3 - Preclinical safety data
- Change to section 6.6 - Special precautions for disposal and other handling
- Change to section 7 - Marketing authorisation holder
- Change to section 8 - Marketing authorisation number(s)
- Change to section 9 - Date of first authorisation/renewal of the authorisation
- Change to section 10 - Date of revision of the text
Legal category:Supply through pharmacy only
Updated on 14 December 2020
File name
ie-pil-benylin-day-and-nght-2107-2090.pdf
Reasons for updating
- Change to Section 1 - what the product is
- 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 - driving and using machines
- Change to section 3 - use in children/adolescents
- Change to section 3 - how to take/use
- Change to section 4 - possible side effects
- Change to section 4 - how to report a side effect
- Change to section 6 - what the product contains
- Change to section 6 - what the product looks like and pack contents
- Change to section 6 - date of revision
Updated on 14 December 2020
File name
ie-spc-clean-2090&2107.pdf
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 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 4.7 - Effects on ability to drive and use machines
- Change to section 4.8 - Undesirable effects
- Change to Section 4.8 – Undesirable effects - how to report a side effect
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 5.2 - Pharmacokinetic properties
- Change to section 5.3 - Preclinical safety data
- Change to section 6.6 - Special precautions for disposal and other handling
- Change to section 7 - Marketing authorisation holder
- Change to section 8 - Marketing authorisation number(s)
- Change to section 9 - Date of first authorisation/renewal of the authorisation
- Change to section 10 - Date of revision of the text
Legal category:Supply through pharmacy only
Updated on 02 December 2019
File name
ie pl Benylin Day and Night 1930.pdf
Reasons for updating
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 4 - possible side effects
- Change to section 6 - date of revision
Updated on 02 December 2019
File name
ie-spc V8 benylin day and night 1930.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 26 November 2019
File name
ie spc V9 benylin day and night 1937.pdf
Reasons for updating
- Change to section 4.6 - Pregnancy and lactation
- Change to section 5.3 - Preclinical safety data
Legal category:Supply through pharmacy only
Updated on 20 August 2019
File name
401455877_360123A_LEAFLET_BenylinDayNightTabs_16s_IE_V1R0.pdf
Reasons for updating
- Change to section 3 - overdose, missed or forgotten doses
- Change to section 6 - date of revision
- Change to information for healthcare professionals
Updated on 12 November 2018
File name
ie-pil Benylin Day & Night 1850.pdf
Reasons for updating
- Change to section 6 - marketing authorisation holder
- Change to section 6 - date of revision
Updated on 12 November 2018
File name
ie-spc V7 BEH02 1850.pdf
Reasons for updating
- Change to section 7 - Marketing authorisation holder
- Change to section 8 - Marketing authorisation number(s)
- Change to section 10 - Date of revision of the text
Legal category:Supply through pharmacy only
Updated on 11 July 2018
File name
ie-spc V6 BEH02 1125.docx
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 10 - Date of revision of the text
Legal category:Supply through pharmacy only
Updated on 11 July 2018
File name
ie-pl-proposed (clean) Benylin Day and Night 27 April 2018.pdf
Reasons for updating
- Change to section 2 - interactions with other medicines, food or drink
- Change to section 4 - possible side effects
Updated on 21 July 2011
File name
PIL_10739_141.pdf
Reasons for updating
- New PIL for new product
Updated on 21 July 2011
Reasons for updating
- Improved electronic presentation
Updated on 01 October 2010
Reasons for updating
- Change due to user-testing of patient information
Updated on 29 September 2010
Reasons for updating
- New SPC for new product
Legal category:Supply through pharmacy only
Updated on 29 September 2010
Reasons for updating
- Change to section 6.5 - Nature and contents of container
Legal category:Supply through pharmacy only
Free text change information supplied by the pharmaceutical company
Update to replace the 20 tablet pack with a 16 tablet pack.
Updated on 13 August 2010
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
The date of revision was amended in line with the renewal.
Updated on 12 August 2010
Reasons for updating
- Change to name of manufacturer
Updated on 07 April 2009
Reasons for updating
- Change to section 2 - Qualitative and quantitative composition
- Change to section 6.1 - List of excipients
- Change to section 9 - Date of renewal of authorisation
- Change to section 6.5 - Nature and contents of container
Legal category:Supply through pharmacy only
Free text change information supplied by the pharmaceutical company
Renewal changes:
Inclusion of active and strength in the composition of the product
Inclusion of e numbers where appropriate
Inclusion of detailed description of the packaging material
Revision of renewal date
Updated on 07 April 2009
Reasons for updating
- Change to date of revision
- Change of trade or active ingredient name
Updated on 25 August 2008
Reasons for updating
- Change to marketing authorisation holder
Updated on 11 March 2008
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
Change to the name of the MAH from Pfizer Consumer Healthcare, Pottery Road Dun Laoghaire, Co. Dublin to McNeil Healthcare (Ireland) Limited, Airton Road, Tallaght, Dublin 24
Updated on 24 August 2007
Reasons for updating
- Change to section 6.4 - Special precautions for storage
Legal category:Supply through pharmacy only
Free text change information supplied by the pharmaceutical company
section 6.4 chagned to Do not store above 25°C. Store in original container.
Updated on 28 February 2006
Reasons for updating
- New PIL for medicines.ie
Updated on 16 June 2003
Reasons for updating
- New SPC for medicines.ie
Legal category:Supply through pharmacy only