Benylin Children's Chesty Coughs *

When a pharmaceutical company changes any document, a new version is published on medicines.ie. For each version, we show the dates it was published on medicines.ie and the reasons for change.

Updated on 09 July 2021

File name

ie-lealet-proposed-benylin-children-chesty-2094_1625861939.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_1620053121.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_1620053001.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_1603465956.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_1603463393.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_1560771995.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

Section 6.5:

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

Section 6.1

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 6 to 12 years:-  "Use only when simple measures have failed to bring adequate relief.  Use for more than 5 consecutive days is not recommended" has been added.
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

Inclusion of child resistant cap.

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

Inclusion of additional 2 piece child resistant container closure system.

Updated on 02 September 2008

Reasons for updating

  • Change of trade or active ingredient name
  • Change of inactive ingredient

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

Renewal Changes made:
 
Section 1 - Change from Benylin Children's Chesty Cough to Benylin Children's Chesty Cough 50mg/5ml Syrup
 
Section 2 - Inclusion of excipient sorbitol liquid
 
Section 6.1 - Includion of E numbers after excipients (where relevant)

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

Added to section 4.4:
 
 

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.

Consult a pharmacist or other healthcare professional before use in children under 6 years.

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