Lemsip Chesty Cough 50 mg/5 ml Oral Solution
*Company:
Reckitt Benckiser Ireland LimitedStatus:
No Recent UpdateLegal Category:
Supply through general saleActive Ingredient(s):
*Additional information is available within the SPC or upon request to the company
Updated on 04 August 2022
File name
PIL Lemsip Chesty Cough TR2306478A - CRN009ZRT.pdf
Reasons for updating
- Change to section 4 - possible side effects
Updated on 27 October 2021
File name
SPC Lemsip Chesty Cough CRN009ZRT.pdf
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
Legal category:Supply through general sale
Updated on 15 January 2020
File name
Lemsip Chesty Cough 50 mg-5 ml Oral Solution.pdf
Reasons for updating
- Change to section 6 - manufacturer
Updated on 31 August 2016
Reasons for updating
- New SPC for new product
Legal category:Supply through general sale
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
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 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.
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."
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