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GlaxoSmithKline Consumer Healthcare (Ireland) Ltd
Stonemason's Way, Rathfarnham, Dublin 16,
Telephone: +353 1 495 5000
Fax: +353 1 495 5105
Medical Information Direct Line: +353 1 800 244 255
Medical Information Facsimile: +353 1 495 5242
Summary of Product Characteristics last updated on medicines.ie: 02/07/2010
SPC Panadol Cold & Flu Hot Lemon with Honey 600 mg/40 mg Powder for Oral Solution

When a pharmaceutical company changes an SPC or PIL, 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 02/07/2010 and displayed until Current
Reasons for adding or updating:
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects
  • Change to section 4.9 - Overdose
  • Change to section 10 - Date of revision of the text
Date of revision of text on the SPC:   22-Apr-2010
Legal Category:   Supply through general sale

Free-text change information supplied by the pharmaceutical company

  • In section 4.2 (Posology and Method of Administration), “Do not take more often than every 4 hours. Do not take more than 6 sachets in any 24 hours.” was added.

 

  • In section 4.4  (Special Warnings and Precautions for use),” Contains 136mg sodium per dose. To be taken into account by patients on a sodium-controlled diet.” was added.

 

  • In section 4.8 (Undesirable effects),text on skin rashes and other allergies and also text on thrombocytopenia and agranulocytosis was removed and replaced by information on classification of undesirable effects, including very common, common, uncommon, rare, very rare and not known, this information was then tabulated by blood system, undesirable effect and frequency.
  •  In section 4.9 (overdose),  a new heading for “paracetamol” was added and so was a subheading of “Symptoms and signs” and another subheading of “Treatment”. Another heading for Ascorbic acid was added and new information detailing potential of overdose was also added.

 

  • In section 10 (Date of revision of text) the date was changed to April 2010.
Updated on 19/08/2008 and displayed until 02/07/2010
Reasons for adding or 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 10 - Date of revision of the text
Date of revision of text on the SPC:   07/2008
Legal Category:   general sale

Free-text change information supplied by the pharmaceutical company

- section 4.4: Caution is advised in the administration of paracetamol to patients with impaired renal and hepatic function or if they are taking other drugs that affect the liver. The hazard of overdose is greater in those with non-cirrhotic alcoholic liver disease.

Keep out of the reach and sight of children.

- section 4.5: Paracetamol is reported to increase the half-life of chloramphenicol. The speed of absorption of paracetamol may be increased by metoclopramide or domperidone and absorption reduced by cholestyramine. The anticoagulant effect of warfarin and other coumarins may be enhanced by prolonged regular daily use of paracetamol with increased risk of bleeding; occasional doses have no significant effect. The hepatotoxicity of paracetamol may be potentiated by other drugs that affect the liver.

- section 4.8: Skin rashes and other allergic reactions occur occasionally with paracetamol. There have been very rare reports of blood dyscrasias including thrombocytopenia and agranulocytosis but these were not necessarily causally related to paracetamol.

- section 10: July 2008
Updated on 31/07/2008 and displayed until 19/08/2008
Reasons for adding or updating:
  • Change to section 9 - Date of renewal of authorisation
Date of revision of text on the SPC:   07/2008
Legal Category:   general sale

Free-text change information supplied by the pharmaceutical company

Section 9 - correct date of last renewal is 20 October 2007
Updated on 02/07/2008 and displayed until 31/07/2008
Reasons for adding or updating:
  • Change to section 1 - Name of medicinal product
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 6.5 - Nature and contents of container
  • Change to section 9 - Date of renewal of authorisation
  • Change to section 10 - Date of revision of the text
Date of revision of text on the SPC:   03/2008
Legal Category:   general sale

Free-text change information supplied by the pharmaceutical company

Sections 1, 2, 5.1, 6.5, 6.6, 9 and 10 (text changed). all are renewal changes

Sections 3, 4.6 and 5.3 need typo/formatting corrections i.e.

3. Powder for oral solution - not to be in italic and in bold format correction

4.6 - random letters at the end of section to be deleted typo correction

5.3 - text in second line to be connected with the text in first line - all is one sentence.format correction
Updated on 14/02/2007 and displayed until 02/07/2008
Reasons for adding or updating:
  • Change to section 4.4 - Special warnings and precautions for use
Date of revision of text on the SPC:   01/2007
Legal Category:   general sale

Free-text change information supplied by the pharmaceutical company
Section 4.4.
The following is added:

Patients with rare hereditary problems of fructose intolerance, glucose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine.
Updated on 21/08/2006 and displayed until 14/02/2007
Reasons for adding or updating:
  • New SPC for new product

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Active Ingredients

 
  Paracetamol
  Ascorbic acid