Lemsip Chesty Cough 50 mg/5 ml Oral Solution *

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 15 January 2020

File name

Lemsip Chesty Cough 50 mg-5 ml Oral Solution_1579098462.pdf

Reasons for updating

  • Change to section 6 - manufacturer

Updated on 31 August 2016

Reasons for updating

  • Change to section 4.1 - Therapeutic indications
  • 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
  • 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 4.8 – Undesirable effects - how to report a side effect
  • Change to section 4.9 - Overdose
  • Change to section 5.1 - Pharmacodynamic properties

Legal category:Supply through general sale

Free text change information supplied by the pharmaceutical company

Section 4.1:
Addition  of "an expectorant for the ..... symptomatic relief of deep chesty coughs"

Section 4.2:
Addition of further information regarding posology:
"Not recommended" replaced by "contraindicated" for children under 12 years
Addition of Elderly population dosage
Addition of Method of Administration

Section 4.3:
Addition of "do not take if suffering from porphyria"

Section 4.4:
Addition of-
"Seek medical advise if suffering from chronic cough or asthma"
"Use with caution in patients with renal impairment"
"Not recommended for concomitant use with a cough suppressant"
"Do not take if you are pregnant or breast feeding, unless recommended by a health care professional (see section 4.6)"
"Not recommended" replaced by "contraindicated" for children under 12 years

Section 4.6:
Pregnancy paragraph deleted and replaced with "The product should not be used during pregnancy unless recommended by a healthcare professional.  There are limited data on the use of guaifenesin in pregnant women"
Breast feeding paragraph has addition of "The product should be avoided during lactation unless recommended by a healthcare professional"

Section 4.7:
Text changed from "not relevant" to "The product has no or negligible influence on the ability to drive and use machines"

Section 4.8:
Addition of MEDdra table.
Addition of Reporting of Suspected Adverse Reaction information

Section 4.9:
Replacement of text to:
"Symptoms associate with Guaifenesin overdose include headache, dizziness, nausea and vomiting.  Extremely high doses may depress the central nervous system and act as a muscle relaxant.  Prolonged use of guaifenesin may result urolithiasis.  The drug is, however, rapidly metabolised and excreted in the urine/

Section 5.1:
Addition of:
Pharmacotherapeutic Group: Respiratory system, Cough and cold preparations, expectorants

 




Updated on 31 August 2016

Reasons for updating

  • New SPC for new product

Legal category:Supply through general sale

Updated on 30 August 2016

File name

PIL_16844_61.pdf

Reasons for updating

  • New PIL for new product

Updated on 24 July 2013

Reasons for updating

  • Change to section 4.1 - Therapeutic indications
  • 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
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • 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
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 5.2 - Pharmacokinetic properties

Legal category:Supply through general sale

Free text change information supplied by the pharmaceutical company

SPC updated to be in line with CCDS

Updated on 22 May 2012

Reasons for updating

  • Change to section 3 - Pharmaceutical form

Legal category:Supply through general sale

Free text change information supplied by the pharmaceutical company

Colurless solution with characteristic lemon odour udpated to

pale yellow or colourless solution with charactersitic lemon odour.

Updated on 07 September 2011

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • 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 general sale

Free text change information supplied by the pharmaceutical company

Section 2, "Each 5ml of oral solution contains 4g of sucrose" has been added.

Section 4.2 Indication in under 12s removed and "Not recommended for children under 12 years" added.

Section 4,3 "Contraindicated in children under 12 years of age" added.

Section 4.4 " Not recommended for children under 12 years" added and "Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine."

Updated on 04 March 2009

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.4 - Special warnings and precautions for use

Legal category:Supply through general sale

Free text change information supplied by the pharmaceutical company

Update to section 4.2 & 4.4
 
Restriction of use in children under 2 years, increased warnings for use in children aged 2-6 years.

Updated on 27 August 2007

Reasons for updating

  • New SPC for new product

Legal category:Supply through general sale