Benylin Four Flu 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 02 August 2024
File name
ie-leaflet-clean-benylin-4-flu-2561.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 02 August 2024
File name
ie-spc-clean-benylin-4-flu-2561.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
Updated on 19 July 2024
File name
ie-leaflet-proposed-clean-benylin-4-flu-rfi-2552.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 19 July 2024
File name
ie-spc-v16-clean-benylin-4-flu-2552.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 29 April 2024
File name
ie-pil-benylin-four-flu-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-v15 benylin-4-flu-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 04 March 2023
File name
ie-mockup-pl-clean-3762-2309.pdf
Reasons for updating
- Change to section 6 - marketing authorisation holder
- Change to section 6 - date of revision
Updated on 31 January 2023
File name
ie-spc-clean-rfi-2183.pdf
Reasons for updating
- 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 31 January 2023
File name
ie-mockup-pl-clean-benylinfourflu-2183-rfi.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 10 May 2022
File name
ie-mockup-pl-clean-benylinfourflu-2211.pdf
Reasons for updating
- Change to section 4 - how to report a side effect
Updated on 02 November 2021
File name
402567809_Benylin_360138F_EMEA_2021_00012973_002_r0.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 3 - overdose, missed or forgotten doses
- Change to section 4 - possible side effects
- Change to section 6 - date of revision
Updated on 02 November 2021
File name
ie-spc-v13-benylin-4-flu-2038.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 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
Updated on 18 September 2020
File name
BEN02 2074 SPC V12.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 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 18 September 2020
File name
ie-mockup-pl-benylinfourflu-2074.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 23 December 2019
File name
ie-mockup-pl-benylin4flutablets-1933.pdf
Reasons for updating
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 2 - excipient warnings
- Change to section 4 - possible side effects
- Change to section 6 - what the product contains
- Change to section 6 - date of revision
Updated on 23 December 2019
File name
BEN02 1933 SPC V11.1.pdf
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.6 - Pregnancy and lactation
- Change to section 4.8 - Undesirable effects
- 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 13 September 2019
File name
401360964_360138C_PIL_BenylinFourFluTablets_IE_r6 - 1625.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 - use in children and adolescents
- Change to section 2 - interactions with other medicines, food or drink
- Change to section 2 - driving and using machines
- Change to section 3 - dose and frequency
- Change to section 3 - overdose, missed or forgotten doses
- Change to section 4 - possible side effects
- Change to section 4 - how to report a side effect
- Change to section 5 - how to store or dispose
- Change to section 6 - what the product contains
- Change to section 6 - date of revision
Updated on 13 September 2019
File name
BEN02 1625 SPC V10.pdf
Reasons for updating
- Change to section 3 - Pharmaceutical form
- 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 4.8 – Undesirable effects - how to report a side effect
- Change to section 4.9 - Overdose
- Change to section 6.5 - Nature and contents of container
- 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 10 - Date of revision of the text
Legal category:Supply through pharmacy only
Updated on 05 December 2018
File name
ie-mockup-pl-benylinfourflutablets-1778.pdf
Reasons for updating
- Change to section 6 - marketing authorisation holder
Updated on 05 December 2018
File name
ie-spc-clean-1778.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 19 January 2017
Reasons for updating
- New SPC for new product
Legal category:Supply through pharmacy only
Updated on 19 January 2017
Reasons for updating
- 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
For oral use
Adults, the elderly and children aged 12
16 years and over:
Two tablets, up to four times daily, as required. Do not take more
frequently than every four hours
Children 6
10 to 12 15 years
One tablet, up to four times daily, as required. Do not take more
frequently than every four hours. Not to be used for more than five
days without the advice of a doctor. Parents or carers should seek
medical attention if the child’s condition deteriorates during treatment.
Children under 6
10 years
Benylin Four Flu Tablets are contraindicated in children under the age
of 6
10 years (see section 4.3).
Do not exceed the stated dose.
4.3 Contraindications
Known hypersensitivity to diphenhydramine, paracetamol,
pseudoephedrine or to any of the excipients.
Concomitant use of other sympathomimetic agents including those
given by other routes, beta-blockers (see section 4.5) and monoamine
oxidase inhibitors (MAOIs), or within 14 days of stopping MAOI
treatment (see section 4.5)
Cardiovascular disease including hypertension
Diabetes mellitus
Phaeochromocytoma
Hyperthyroidism
Closed angle glaucoma
Severe renal impairment
Not to be used in children under the age of 6
10 years.
10 DATE OF REVISION OF THE TEXT
06-January-2017
Updated on 13 January 2017
File name
PIL_9059_146.pdf
Reasons for updating
- New PIL for new product
Updated on 13 January 2017
Reasons for updating
- Change to section 1 - what the product is used for
- Change to section 2 - use in children and adolescents
- Change to section 3 - use in children/adolescents
- Change to section 3 - how to take/use
- Change to section 4 - how to report a side effect
- Change to section 5 - how to store or dispose
- Change to section 6 - date of revision
Updated on 08 April 2013
Reasons for updating
- Change to date of revision
- Change to name of manufacturer
Updated on 21 July 2011
Reasons for updating
- Change of manufacturer
Updated on 21 July 2011
Reasons for updating
- Change due to user-testing of patient information
Updated on 02 June 2010
Reasons for updating
- Change to warnings or special precautions for use
Updated on 01 June 2010
Reasons for updating
- Change to section 4.2 - Posology and method of administration
- Change to section 4.3 - Contraindications
Legal category:Supply through pharmacy only
Free text change information supplied by the pharmaceutical company
Updated on 25 August 2008
Reasons for updating
- Change to marketing authorisation holder
Updated on 22 August 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
Updated on 28 February 2006
Reasons for updating
- Correction of spelling/typing errors
Updated on 04 October 2004
Reasons for updating
- Change to section 4.2 - Posology and method of administration
Legal category:Supply through pharmacy only
Updated on 30 September 2004
Reasons for updating
- Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
Legal category:Supply through pharmacy only
Updated on 28 September 2004
Reasons for updating
- New PIL for medicines.ie
Updated on 11 August 2003
Reasons for updating
- New SPC for medicines.ie
Legal category:Supply through pharmacy only