Benylin Non- Drowsy for Chesty Coughs
*Company:
KenvueStatus:
No Recent UpdateLegal Category:
Supply through general saleActive Ingredient(s):
*Additional information is available within the SPC or upon request to the company
Updated on 29 April 2024
File name
ie-pil-benylin-non-drowsy-chesty-coughs-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 v8 Benylin ND Chesty-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 general sale
Updated on 23 January 2022
File name
402649795_Benylin_nd_chesty_LN516404_EMEA_2021_00022381_002_r1.pdf
Reasons for updating
- Change to section 2 - excipient warnings
- Change to section 6 - date of revision
Updated on 23 January 2022
File name
ie-spc v7 benylin nd chesty 2195.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 general sale
Updated on 03 May 2021
File name
ie-leaflet-proposed-benylin-non-drowsy-chesty 2094.pdf
Reasons for updating
- Change to section 2 - excipient warnings
- Change to section 6 - what the product contains
- Change to section 6 - date of revision
Updated on 03 May 2021
File name
ie-spc V6 Benylin ND Chesty 2094.pdf
Reasons for updating
- Change to section 2 - Qualitative and quantitative composition
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 6.1 - List of excipients
- Change to section 10 - Date of revision of the text
Legal category:Supply through general sale
Updated on 23 October 2020
File name
ie-pl-benylin-nd-chesty-2058.pdf
Reasons for updating
- Change to section 6 - manufacturer
- Change to section 6 - date of revision
Updated on 17 June 2019
File name
ie-spc V5 (clean) Benylin ND Chesty 1731.pdf
Reasons for updating
- File format updated to PDF
Legal category:Supply through general sale
Updated on 05 June 2018
File name
LN516401-PIL BENYLIN CHESTY COUGHS ND 125MLv7_2_v1_FVID430204.pdf
Reasons for updating
- Change to section 6 - marketing authorisation number
Updated on 05 June 2018
File name
ie-spc V5 (tracked) Benylin ND Chesty 1731.docx
Reasons for updating
- Change to section 7 - Marketing authorisation holder
- Change to section 8 - Marketing authorisation number(s)
Legal category:Supply through general sale
Updated on 29 July 2015
File name
PIL_10410_277.pdf
Reasons for updating
- New PIL for new product
Updated on 29 July 2015
Reasons for updating
- Improved electronic presentation
Updated on 10 March 2015
Reasons for updating
- New SPC for new product
Legal category:Supply through general sale
Updated on 10 March 2015
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 4.7 - Effects on ability to drive and use machines
- Change to Section 4.8 – Undesirable effects - how to report a side effect
- Change to section 4.9 - Overdose
- Change to section 10 - Date of revision of the text
Legal category:Supply through general sale
Free text change information supplied by the pharmaceutical company
Section 4.4 - information on excipients added
Section 4.6 updated as follows:
Pregnancy
There are no or limited amounts of data from the use of Guaifenesin in pregnant women. Animal studies are insufficient with respect to reproductive toxicity (see section 5.3). Benylin Non-Drowsy Chesty Coughs is not recommended during pregnancy and in women of childbearing potential not using contraception.
Breastfeeding
Guaifenesin is excreted in breast milk in small amounts. There is insufficient information on the effects of Guaifenesin in newborns/infants. A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from Benylin Non-Drowsy Chesty Coughs therapy, taking into account the benefit of breast feeding for the child and the benefit of therapy for the woman.
Fertility
There is insufficient information available to determine whether guaifenesin has the potential to impair fertility
Section 4.7 - updated as follows:
It is not expected that this product would interfere with the ability to drive or operate machinery
Section 4.8 updated as follows & HPRA details for AE reporting added:
|
Body System (SOC) |
Frequency |
Adverse Drug Reaction (Preferred Term) |
|
Immune system Disorders |
Not known |
Hypersensitivity (including Pruritus and Urticaria)
|
|
Gastrointestinal Disorders |
Not known Not known Not known Not known |
Abdominal pain upper Diarrhoea Nausea Vomiting
|
|
Skin and Subcutaneous Tissue Disorders |
Not known |
Rash |
Section 4.9 updated as follows:
Symptoms and signs
Guaifenesin
The symptoms and signs of overdose may include gastro-intestinal discomfort, nausea and somnolence. When taken in excess, Guaifenesin may cause renal calculi.
Menthol
Excessive use of menthol may lead to abdominal pain, vomiting, flushed face, dizziness, weakness, tachycardia, stupor, and ataxia
Updated on 09 March 2015
Reasons for updating
- Change to side-effects
Updated on 01 October 2010
Reasons for updating
- Change due to user-testing of patient information
Updated on 21 September 2009
Reasons for updating
- Change to dosage and administration
Updated on 14 September 2009
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 general sale
Free text change information supplied by the pharmaceutical company
Section 4.2:
Indication for use in children under 12 removed.
Section 4.3:
Contraindication not to use in children under 12 added.
Section 10:
Changed to June 2009
Updated on 13 November 2008
Reasons for updating
- Change to section 6.5 - Nature and contents of container
Legal category:Supply through general sale
Free text change information supplied by the pharmaceutical company
Updated on 25 August 2008
Reasons for updating
- Change to marketing authorisation holder
Updated on 05 June 2008
Reasons for updating
- Change to section 7 - Marketing authorisation holder
Legal category:Supply through general sale
Free text change information supplied by the pharmaceutical company
Updated on 19 May 2008
Reasons for updating
- Change to marketing authorisation holder
Updated on 12 September 2005
Reasons for updating
- New PIL for new product
Updated on 11 June 2003
Reasons for updating
- New SPC for medicines.ie
Legal category:Supply through general sale