Lemsip Max Cold & Flu Hot Lemon 1000mg Powder for 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
SPC Lemsip Max CF Hot Lemon clean Dec21 CRN00CCMK.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
PIL Lemsip Max C&F hot lemon 1000mg TR2393502C - Zippy - CRN00CCMK.pdf
Reasons for updating
- Change to section 4 - possible side effects
Updated on 27 October 2021
File name
SPC Lemsip Max CF Hot Lemon.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
PIL Lemsip Max C&F hot lemon 1000mg.pdf
Reasons for updating
- Change to section 2 - pregnancy, breast feeding and fertility
- Change to section 3 - use in children/adolescents
Updated on 15 January 2020
File name
Lemsip Max Cold & Flu Hot Lemon 1000mg Powder for Oral Solution.pdf
Reasons for updating
- Change to section 6 - manufacturer
Updated on 30 June 2016
Reasons for updating
- New SPC for new product
Legal category:Supply through general sale
Updated on 30 June 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
Legal category:Supply through general sale
Free text change information supplied by the pharmaceutical company
Section 4.2 - addition of information for:
Paediatric population posology
Method of administration
Hepatic Impairment
Renal Impairment
Elderly Population
Section 4.3:
Updated to read "Hypersensitivity to paracetamol or to any of the excipients listed in Section 6.1"
Section 4.4 - addition of information for:
Serious skin reactions
Kidney / Liver impairments
Section 4.5:
Removal of the sentence "Drugs, which induce hepatic microsomal enzymes, such as alcohol, barbiturates, monoamine oxidase inhibitors and tricyclic antidepressants, may increase the hepatotoxicity of paracetamol, particularly after overdosage."
Section 4.6:
Pregnancy data updated to read "A large amount of data on pregnant women indicate neither malformative, nor feto-neonatal toxicity. Paracetamol can be used during pregnancy if clinically needed, however it should be used at the lowest effective dose for the shortest possible time and at the lowest possible frequency."
Section 4.8:
Updated to include a MEDdra table of adverse events
Additional paragraph containing HPRA details for reporting of suspected adverse reactions.
Section 4.9:
Overdose data updated to read
"There is a risk of poisoning, particularly in elderly subjects, in young children, in patients with liver disease, in cases of chronic alcoholism, in patients with chronic malnutrition. Overdosing may be fatal in these cases. Symptoms generally appear within the first 24 hours and comprise: nausea, vomiting, anorexia, pallor, and abdominal pain. Overdose of paracetamol in a single administration in adults or in children causes liver cell necrosis likely to induce complete and irreversible necrosis, resulting in hepatocellular insufficiency, metabolic acidosis and encephalopathy which may lead to coma and death. Simultaneously, increased levels of hepatic transaminases (AST, ALT), lactate dehydrogenase and bilirubin are observed together with increased prothrombin levels that may appear 12 to 48 hours after administration.
Liver damage is likely in adults who have taken more than the recommended amounts of paracetamol. It is considered that excess quantities of toxic metabolite (usually adequately detoxified by glutathione when normal doses of paracetamol are ingested), become irreversibly bound to liver tissue.
Some patients may be at increased risk of liver damage from paracetamol toxicity.
Risk Factors include:
If the patient; a. Is on long-term treatment with carbamazepine, phenobarbitone, phenytoin, primidone, rifampicin, St John’s Wort or other drugs that induce liver enzymes. Or b. Regularly consumes ethanol in excess of recommended amounts Or c. Is likely to be glutathione depleted e.g. eating disorders, cystic fibrosis, HIV infection, starvation, cachexia.
Emergency Procedure: Immediate transfer to hospital. Blood sampling to determine initial paracetamol plasma concentration.
Gastric lavage. IV (or oral if possible) administration of the antidote N-acetylcysteine as soon as possible and before the 10th hour of the overdose in accordance with National guidelines. Symptomatic treatment should be implemented.”
Paediatric population posology
Method of administration
Hepatic Impairment
Renal Impairment
Elderly Population
Section 4.3:
Updated to read "Hypersensitivity to paracetamol or to any of the excipients listed in Section 6.1"
Section 4.4 - addition of information for:
Serious skin reactions
Kidney / Liver impairments
Section 4.5:
Removal of the sentence "Drugs, which induce hepatic microsomal enzymes, such as alcohol, barbiturates, monoamine oxidase inhibitors and tricyclic antidepressants, may increase the hepatotoxicity of paracetamol, particularly after overdosage."
Section 4.6:
Pregnancy data updated to read "A large amount of data on pregnant women indicate neither malformative, nor feto-neonatal toxicity. Paracetamol can be used during pregnancy if clinically needed, however it should be used at the lowest effective dose for the shortest possible time and at the lowest possible frequency."
Section 4.8:
Updated to include a MEDdra table of adverse events
Additional paragraph containing HPRA details for reporting of suspected adverse reactions.
Section 4.9:
Overdose data updated to read
"There is a risk of poisoning, particularly in elderly subjects, in young children, in patients with liver disease, in cases of chronic alcoholism, in patients with chronic malnutrition. Overdosing may be fatal in these cases. Symptoms generally appear within the first 24 hours and comprise: nausea, vomiting, anorexia, pallor, and abdominal pain. Overdose of paracetamol in a single administration in adults or in children causes liver cell necrosis likely to induce complete and irreversible necrosis, resulting in hepatocellular insufficiency, metabolic acidosis and encephalopathy which may lead to coma and death. Simultaneously, increased levels of hepatic transaminases (AST, ALT), lactate dehydrogenase and bilirubin are observed together with increased prothrombin levels that may appear 12 to 48 hours after administration.
Liver damage is likely in adults who have taken more than the recommended amounts of paracetamol. It is considered that excess quantities of toxic metabolite (usually adequately detoxified by glutathione when normal doses of paracetamol are ingested), become irreversibly bound to liver tissue.
Some patients may be at increased risk of liver damage from paracetamol toxicity.
Risk Factors include:
If the patient; a. Is on long-term treatment with carbamazepine, phenobarbitone, phenytoin, primidone, rifampicin, St John’s Wort or other drugs that induce liver enzymes. Or b. Regularly consumes ethanol in excess of recommended amounts Or c. Is likely to be glutathione depleted e.g. eating disorders, cystic fibrosis, HIV infection, starvation, cachexia.
Emergency Procedure: Immediate transfer to hospital. Blood sampling to determine initial paracetamol plasma concentration.
Gastric lavage. IV (or oral if possible) administration of the antidote N-acetylcysteine as soon as possible and before the 10th hour of the overdose in accordance with National guidelines. Symptomatic treatment should be implemented.”
Updated on 29 June 2016
File name
PIL_14948_102.pdf
Reasons for updating
- New PIL for new product
Updated on 29 June 2016
Reasons for updating
- Change to side-effects
- Change to information about pregnancy or lactation
- Change to dosage and administration
Updated on 11 June 2015
Reasons for updating
- Introduction of new pack/pack size
Updated on 05 March 2015
Reasons for updating
- 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
Free text change information supplied by the pharmaceutical company
Section 4.4 - added: Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine
Section 6.1 - added: lactose, polysorbate 80, silica, and curcumin
Section 10 - Updated to January 2014
Section 6.1 - added: lactose, polysorbate 80, silica, and curcumin
Section 10 - Updated to January 2014
Updated on 12 January 2015
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 10s sachet pack size
Updated on 23 April 2013
Reasons for updating
- 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 4.8 - Undesirable effects
- Change to section 4.9 - Overdose
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 6.3 - Shelf life
Legal category:Supply through general sale
Free text change information supplied by the pharmaceutical company
- Rewording of information in section: 4.4
- Updated information in sections: 4.5, 4.8 & 4.8
- Inclusion of ATC code in Section 5.1
- Section 6.3 change the word 'three' to the digit 3
Updated on 30 March 2011
Reasons for updating
- New PIL for medicines.ie
Updated on 08 March 2010
Reasons for updating
- Change to section 1 - Name of medicinal product
- Change to section 9 - Date of renewal of authorisation
- 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
Addition of strength and pharmaceutical form to teh naem as a result of license renewal
Updated on 20 March 2009
Reasons for updating
- 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
Addition of ecipient warnings to section 4.4 of SPC
Updated on 15 May 2007
Reasons for updating
- Change to marketing authorisation holder address
Legal category:Supply through general sale
Free text change information supplied by the pharmaceutical company
SECTION 7. Change of address of marketing authorisation holder to: 7 Riverwalk, Citywest Business Campus, Dublin 24, Ireland.
Updated on 29 August 2006
Reasons for updating
- Change to section 2 - Qualitative and quantitative composition
- Change to section 6.1 - List of excipients
- 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 2: Qualitative and Quantitative Composition - Remove ascorbic acid as an acitive
Section 6.1: List of Excipients - Needs to be changed to : Sucrose, citric acid anhydrous, sodium citrate, lemon flavour no. 1, aspartame E951, saccharin sodium, ascorbic acid and curcumin
Section 10: Date of (partial) Revision of the Text - Needs to be April 2006
Updated on 19 May 2005
Reasons for updating
- Improved electronic presentation
Legal category:Supply through general sale
Updated on 10 August 2004
Reasons for updating
- Improved electronic presentation
Legal category:Supply through general sale
Updated on 16 June 2003
Reasons for updating
- New SPC for medicines.ie
Legal category:Supply through general sale