Benylin Non- Drowsy for 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 03 May 2021

File name

ie-leaflet-proposed-benylin-non-drowsy-chesty 2094_1620052657.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_1620052532.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_1603462464.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_1560772430.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

Addition of HDPE plastic cap with PE-Alu-PET wad material.

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

Change in MAH from Pfizer Consumer Healthcare, Pottery Road, Dun Laoghaire to McNeil Healthcare Ireland Limited, Airton Road, Tallaght, Dublin 24.

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