Benylin Children's Chesty Coughs
- Name:
Benylin Children's Chesty Coughs
- Company:
Johnson & Johnson (Ireland) Ltd
- Active Ingredients:
- Legal Category:
Supply through pharmacy only
Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 26/04/18
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Johnson & Johnson (Ireland) Ltd
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Company Products
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 17 June 2019 SmPC
Reasons for updating
- File format updated to PDF
Legal category: Supply through pharmacy only
Updated on 2 May 2018 SmPC
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 PIL
Reasons for updating
- Company name change or merger
Updated on 24 April 2018 SmPC
Reasons for updating
- Change to section 8 - Marketing authorisation number(s)
Legal category: Supply through pharmacy only
Updated on 29 July 2015 PIL
Reasons for updating
- New PIL for new product
Updated on 29 July 2015 PIL
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 SmPC
Reasons for updating
- New SmPC for new product
Legal category: Supply through pharmacy only
Updated on 14 July 2015 SmPC
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 6 February 2014 SmPC
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 4 February 2014 PIL
Reasons for updating
- Change to dosage and administration
Updated on 3 February 2014 SmPC
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 SmPC
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 PIL
Reasons for updating
- Change to warnings or special precautions for use
- Change of contraindications
- Change to dosage and administration
Updated on 28 April 2011 SmPC
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 6 December 2010 SmPC
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 1 October 2010 PIL
Reasons for updating
- Change due to user-testing of patient information
Updated on 13 January 2010 SmPC
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 2 September 2008 PIL
Reasons for updating
- Change of trade or active ingredient name
- Change of inactive ingredient
Updated on 2 September 2008 SmPC
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 9 July 2008 PIL
Reasons for updating
- Change to warnings or special precautions for use
Updated on 25 June 2008 SmPC
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 PIL
Reasons for updating
- Change to marketing authorisation holder
Updated on 11 March 2008 SmPC
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 PIL
Reasons for updating
- Change of manufacturer
Updated on 21 September 2004 SmPC
Reasons for updating
- Improved electronic presentation
Legal category: Supply through pharmacy only
Updated on 10 September 2004 PIL
Reasons for updating
- New PIL for medicines.ie
Updated on 12 June 2003 SmPC
Reasons for updating
- New SPC for medicines.ie
Legal category: Supply through pharmacy only