Lemsip Max Cough & Cold, Powder for Oral Solution, Paracetamol 1000mg, Guaifenesin 200mg
- Name:
Lemsip Max Cough & Cold, Powder for Oral Solution, Paracetamol 1000mg, Guaifenesin 200mg
- Company:
Reckitt Benckiser Ireland Limited
- Active Ingredients:
- Legal Category:
Supply through general sale
Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 15/01/20
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1. NAME OF THE MEDICINAL PRODUCT
1. NAME OF THE MEDICINAL PRODUCT
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
3. PHARMACEUTICAL FORM
3. PHARMACEUTICAL FORM
4. CLINICAL PARTICULARS
4. CLINICAL PARTICULARS
5. PHARMACOLOGICAL PROPERTIES
5. PHARMACOLOGICAL PROPERTIES
6. PHARMACEUTICAL PARTICULARS
6. PHARMACEUTICAL PARTICULARS
7. MARKETING AUTHORISATION HOLDER
7. MARKETING AUTHORISATION HOLDER
8. MARKETING AUTHORISATION NUMBER(S)
8. MARKETING AUTHORISATION NUMBER(S)
9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
10. DATE OF REVISION OF THE TEXT
10. DATE OF REVISION OF THE TEXT
Reckitt Benckiser Ireland Limited
Company Products
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 PIL
Reasons for updating
- Change to section 6 - manufacturer
Updated on 17 February 2017 PIL
Reasons for updating
- New PIL for new product
Updated on 17 February 2017 PIL
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 1 December 2016 SPC
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
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 1 December 2016
Reasons for updating
- New SmPC for new product
Legal category: Supply through general sale
Updated on 21 April 2016 SPC
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
Lactose warning added to SmPC
Updated on 4 August 2015 PIL
Reasons for updating
- Change to warnings or special precautions for use
Updated on 22 July 2015 SPC
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
Updated on 30 March 2011 SPC
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
Updated on 30 March 2011 PIL
Reasons for updating
- New PIL for medicines.ie
Updated on 3 October 2007 SPC
Reasons for updating
- New SPC for new product
Legal category: Supply through general sale