Benylin Phlegm Cough Syrup
*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 23 January 2022
File name
402649743_Benylin_phlegm_cough_LN516504_EMEA_2021_00029566_002_r1.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 23 January 2022
File name
ie-spc v7 benylin phlegm cough 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-phlegm-cough 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 Phlegm Cough 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-phlegm-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-spcv5(clean)BenylinPhlegmCough1732.pdf
Reasons for updating
- File format updated to PDF
Legal category:Supply through general sale
Updated on 12 June 2018
File name
ie-spcv5(tracked)BenylinPhlegmCough1732.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 12 June 2018
File name
LN516501-PIL BENYLIN PHLEGM COUGH SYRUP 125MLv4_0_v1_FVID430228.pdf
Reasons for updating
- Change to section 6 - marketing authorisation holder
Updated on 20 June 2016
Reasons for updating
- New SPC for new product
Legal category:Supply through general sale
Updated on 20 June 2016
Reasons for updating
- Change to section 1 - Name of medicinal product
- Change to section 6.5 - Nature and contents of container
- 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
1. Name of the Medicinal Product
Benylin Phlegm Cough Syrup
Guaifenesin 100mg/5ml
Levomenthol 1.1mg/5ml Syrup
6.5 Nature and contents of container
Amber glass bottles (pharmacopoeial grade III) with an aluminium ROPP cap with melinex-faced pulpboard wad or with a 3 piece plastic child resistant, tamper evident closure fitted with a PE-Alu-PET or polyethylene/ expanded polyethylene laminated wad or with a plastic HDPE cap fitted with a PE-Alu-PET wad..
Pack sizes: 30 ml, 125 ml, 150ml or 300 ml.
Not all pack sizes may be marketed.
10. Date of revision
June 2016
Updated on 16 June 2016
File name
PIL_15450_918.pdf
Reasons for updating
- New PIL for new product
Updated on 16 June 2016
Reasons for updating
- Change to date of revision
- Addition of information on alternative format leaflets
Updated on 29 July 2015
Reasons for updating
- Improved electronic presentation
Updated on 11 March 2015
Reasons for updating
- 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 general sale
Free text change information supplied by the pharmaceutical company
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 4.8 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 discomfort 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
- Change to information about pregnancy or lactation
Updated on 24 August 2012
Reasons for updating
- New SPC for new product
Legal category:Supply through general sale
Free text change information supplied by the pharmaceutical company
Updated on 23 August 2012
Reasons for updating
- New PIL for new product