Benylin Children's Chesty Coughs
*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 29 April 2024
File name
ie-pil-benylin-childrens-chesty-cough-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 Children's Chesty Cough-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 17 August 2022
File name
ie-pl-clean-benylin-childrens-chesty-2253.pdf
Reasons for updating
- Change to section 4 - how to report a side effect
- Change to section 6 - date of revision
Updated on 17 August 2022
File name
ie-spc-clean-2253.pdf
Reasons for updating
- Change to Section 4.8 – Undesirable effects - how to report a side effect
- Change to section 6.3 - Shelf life
- Change to section 10 - Date of revision of the text
Legal category:Supply through pharmacy only
Updated on 09 July 2021
File name
ie-lealet-proposed-benylin-children-chesty-2094.pdf
Reasons for updating
- Change to section 2 - excipient warnings
- Change to section 6 - what the product looks like and pack contents
- Change to section 6 - date of revision
Updated on 03 May 2021
File name
ie-spc V13 Benylin Children's Chesty 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 V13 Benylin Children's Chesty 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 pharmacy only
Updated on 23 October 2020
File name
ie-pl-benylin-childrens-chesty-2058.pdf
Reasons for updating
- Change to section 6 - manufacturer
- Change to section 6 - date of revision
Updated on 23 October 2020
File name
ie-pl-benylin-childrens-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
benylins_chesty_cough_V12_1649.pdf
Reasons for updating
- File format updated to PDF
Legal category:Supply through pharmacy only
Updated on 02 May 2018
File name
benylins_chesty_cough.docx
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
|
PA Transfer from McNeil Healthcare (Ireland) Ltd to Johnson & Johnson (Ireland) Ltd. |
|
Updated on 26 April 2018
File name
LN513501-PIL BENYLIN CHILDREN CC 125MLv11_1_v3_FVID415272.pdf
Reasons for updating
- Company name change or merger
Updated on 24 April 2018
Reasons for updating
- Change to section 8 - Marketing authorisation number(s)
Legal category:Supply through pharmacy only
Updated on 29 July 2015
File name
PIL_8769_261.pdf
Reasons for updating
- New PIL for new product
Updated on 29 July 2015
Reasons for updating
- Change to warnings or special precautions for use
- Change to instructions about overdose
- Change to side-effects
- Change to information about pregnancy or lactation
- Change to date of revision
Updated on 14 July 2015
Reasons for updating
- New SPC for new product
Legal category:Supply through pharmacy only
Updated on 14 July 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
- Change to section 4.9 - Overdose
Legal category:Supply through pharmacy only
Free text change information supplied by the pharmaceutical company
SNAS 1203
Section 4.4 - warning added
If cough tends to recur or is accompanied by a fever, rash or persistent headache, a physician should be consulted.
Section 4.6 updated as follows:
Section 4.6 updated as follows: Section 4.6 updated as follows:This product has been formulated specifically for children, and would therefore not normally be taken during pregnancy and lactation.
Pregnancy
There are no or limited amount of data from the use of guaifenesin in pregnant women. Animal studies are insufficient with respect to reproductive toxicity (see section 5.3).
BENYLIN Children’s Chesty Cough 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 Children's 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) Adverse Event preferred term |
Frequency Category |
|
Immune System Disorders: Hypersensitivity reactions (Hypersensitivity, pruritus, and urticaria) |
Not known |
|
Rash |
Not known |
|
Gastrointestinal Disorders: |
|
|
Abdominal pain upper |
Not known |
|
Diarrhoea |
Not known |
|
Nausea |
Not known |
|
Vomiting |
Not known |
Section 4.9 updated as follows:
When taken in excess, Guaifenesin may cause renal calculi.
Updated on 06 February 2014
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
Added:
A spoon with a 5 ml and 2.5 ml measure is supplied with the pack.
Updated on 04 February 2014
Reasons for updating
- Change to dosage and administration
Updated on 03 February 2014
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
Strawberry 580.193/T
changed to:
Strawberry Flavour
Updated on 22 July 2011
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
Legal category:Supply through pharmacy only
Free text change information supplied by the pharmaceutical company
Section 4.2:
Removal of indication for use in children under 6 years of age.
Addition of maximum daily dose information
Addition of extra warnings:
Use only when simple measures have failed to provide adequate relief.
Use for more than 5 consecutive days is not recommended
Section 4.3
CI in children under 6.
Section 4.4
Children 2 to 6 years: Not more than 3 doses should be given in any 24 hours.
changed to:
Children 6 to 12 years: Not more than 3 doses should be given in any 24 hours.
Consult a pharmacist or other healthcare professional before use in children under 6 years.
changed to:
Consult a pharmacist or other healthcare professional before use in children under 12 years.
Updated on 21 July 2011
Reasons for updating
- Change to warnings or special precautions for use
- Change of contraindications
- Change to dosage and administration
Updated on 28 April 2011
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
Legal category:Supply through pharmacy only
Free text change information supplied by the pharmaceutical company
Section 4.2 Children aged 2 to 5 years:- This paragraph detailing method of administration has been removed.
Section 4.2 Children under 2 years:- Has been changed to "Children under 6 years".
Section 4.2 Children under 2 years:- "BENYLIN Children's Chesty Coughs is not recommended for administration to children under 2 years of age, except on the advise of a physician" has been changed to "BENYLIN Children's Chesty Coughs is not recommended for administration to children under 6 years of age".
Section 4.3 Contra-indications:- "BENYLIN Children's Chesty Coughs is contra-indiciated in children under 6 years" has been added.
Section 4.4 Special Warnings and special Precautions for use:- "Consult a pharmacist or other healthcare professional before use in children under 6 years" has been changed to "Consult a pharmacist or other healthcare professional before use in children aged 6 to 12 years"
Updated on 06 December 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
Updated on 01 October 2010
Reasons for updating
- Change due to user-testing of patient information
Updated on 13 January 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
Updated on 02 September 2008
Reasons for updating
- Change to section 1 - Name of medicinal product
- Change to section 2 - Qualitative and quantitative composition
- 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 02 September 2008
Reasons for updating
- Change of trade or active ingredient name
- Change of inactive ingredient
Updated on 09 July 2008
Reasons for updating
- Change to warnings or special precautions for use
Updated on 25 June 2008
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
Not more than 4 doses should be given in any 24 hours. Do not exceed the stated dose.
Do not take with any other cough and cold medicine.
Updated on 19 May 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 13 October 2006
Reasons for updating
- Change of manufacturer
Updated on 21 September 2004
Reasons for updating
- Improved electronic presentation
Legal category:Supply through pharmacy only
Updated on 10 September 2004
Reasons for updating
- New PIL for medicines.ie
Updated on 12 June 2003
Reasons for updating
- New SPC for medicines.ie
Legal category:Supply through pharmacy only