Lemsip Max Cough & Cold, Powder for Oral Solution, Paracetamol 1000mg, Guaifenesin 200mg
*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
SPC Lemsip Max Cough Cold Dec21 (Zippy) CRN00CD37.pdf
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
Legal category:Supply through general sale
Updated on 04 August 2022
File name
Leaflet Lemsip Max Cough & Cold 5's TR2393532D- Zippy Dec21 - CRN00CD37.pdf
Reasons for updating
- Change to section 4 - possible side effects
Updated on 27 October 2021
File name
SPC Lemsip Max Cough Cold.pdf
Reasons for updating
- Change to section 4.2 - Posology and method of administration
- Change to section 4.6 - Pregnancy and lactation
Legal category:Supply through general sale
Updated on 27 October 2021
File name
Leaflet Lemsip Max Cough & Cold 5's.pdf
Reasons for updating
- Change to section 2 - use in children and adolescents
- Change to section 2 - pregnancy, breast feeding and fertility
Updated on 15 January 2020
File name
Lemsip Max Cough & Cold, Powder for Oral Solution, Paracetamol 1000mg, Guaifenesin 200mg.pdf
Reasons for updating
- Change to section 6 - manufacturer
Updated on 17 February 2017
File name
PIL_14949_823.pdf
Reasons for updating
- New PIL for new product
Updated on 17 February 2017
Reasons for updating
- Change to section 2 - what you need to know - contraindications
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 3 - how to take/use
- Change to section 4 - possible side effects
- Change to section 4 - how to report a side effect
- Change to section 5 - how to store or dispose
- Improved presentation of PIL
Updated on 01 December 2016
Reasons for updating
- New SPC for new product
Legal category:Supply through general sale
Updated on 01 December 2016
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
- 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 4.8 - 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 4.2:
Additional information added in relation to posology, hepatic and renal impairment, elderly population, method of administration and use with other paracetamol containing products.
Section 4.3:
Addition of hypersensitivity contraindications
Section 4.4:
Addition of data in relation to Serious skin reactions, hepatitis, non-cirrhotic alcohol liver disease, hepatic and renal insufficiency. Excipient warning added in relation to aspartame and phenylalanine.
Section 4.5:
Addition of interactions with anticoagulants, antiemetics, cholestyramine, and laboratory interference.
Section 4.6:
Additional data in relation to pregnancy and breast-feeding.
Section 4.8:
MedDRA table added and undesirable effects added in relation to blood and lymphatic system disorders, gastrointestinal disorders and skin & subcutaneous tissue disorders.
Addition of Reporting of Suspected Adverse Reactions paragraph.
Section 4.9:
Rewording of paragraph to include additional information on paracetamol overdosage
Section 5.1:
Addition of pharmacodynamics properties in relation to Guaifenesin.
Additional information added in relation to posology, hepatic and renal impairment, elderly population, method of administration and use with other paracetamol containing products.
Section 4.3:
Addition of hypersensitivity contraindications
Section 4.4:
Addition of data in relation to Serious skin reactions, hepatitis, non-cirrhotic alcohol liver disease, hepatic and renal insufficiency. Excipient warning added in relation to aspartame and phenylalanine.
Section 4.5:
Addition of interactions with anticoagulants, antiemetics, cholestyramine, and laboratory interference.
Section 4.6:
Additional data in relation to pregnancy and breast-feeding.
Section 4.8:
MedDRA table added and undesirable effects added in relation to blood and lymphatic system disorders, gastrointestinal disorders and skin & subcutaneous tissue disorders.
Addition of Reporting of Suspected Adverse Reactions paragraph.
Section 4.9:
Rewording of paragraph to include additional information on paracetamol overdosage
Section 5.1:
Addition of pharmacodynamics properties in relation to Guaifenesin.
Updated on 21 April 2016
Reasons for updating
- Change to section 6.1 - List of excipients
Legal category:Supply through general sale
Free text change information supplied by the pharmaceutical company
Addition of Lactose added to excipients
Lactose warning added to SmPC
Lactose warning added to SmPC
Updated on 04 August 2015
Reasons for updating
- Change to warnings or special precautions for use
Updated on 22 July 2015
Reasons for updating
- Change to section 2 - Qualitative and quantitative composition
- Change to section 4.3 - Contraindications
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 6.1 - List of excipients
Legal category:Supply through general sale
Free text change information supplied by the pharmaceutical company
The SmPC has been updated as part of renewal. Excipients have been updated in composition section. Update to safety information as a result of renewal
Updated on 30 March 2011
Reasons for updating
- 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
In section 10, revison of text date May 2008 added
Updated on 30 March 2011
Reasons for updating
- New PIL for medicines.ie
Updated on 03 October 2007
Reasons for updating
- New SPC for new product
Legal category:Supply through general sale