Panadol Cold & Flu Hot Lemon 600 mg/40 mg Powder for Oral Solution

*
Pharmacy Only: Non-prescription

Updated on 13 January 2020

File name

ie-spc-panadolcflemon-600-40mg-EM.pdf

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 4.6 - Pregnancy and lactation
  • Change to section 4.8 - Undesirable effects
  • Change to section 4.9 - Overdose
  • Change to section 10 - Date of revision of the text

Legal category:Supply through pharmacy only

Updated on 13 January 2020

File name

ie-pl-panadolcflemon-11-1-gdsv6-rfi-3-190201em-clean.pdf

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 2 - use in children and adolescents
  • Change to section 2 - interactions with other medicines, food or drink
  • Change to section 2 - pregnancy, breast feeding and fertility
  • Change to section 2 - excipient warnings
  • Change to section 3 - duration of treatment
  • Change to section 3 - overdose, missed or forgotten doses
  • Change to section 4 - possible side effects
  • Change to section 4 - how to report a side effect
  • Change to section 6 - date of revision

Updated on 03 September 2018

File name

ie-mockup-leaflet-678-11-1.pdf

Reasons for updating

  • Change to section 2 - use in children and adolescents

Updated on 03 September 2018

File name

ie-spc-678-11-1-clean.pdf

Reasons for updating

  • Change to section 4.2 - Posology and method of administration

Legal category:Supply through pharmacy only

Free text change information supplied by the pharmaceutical company

Paediatric posology changes

Updated on 19 July 2017

File name

PIL_11589_720.pdf

Reasons for updating

  • New PIL for new product

Updated on 19 July 2017

Reasons for updating

  • New SPC for new product

Legal category:Supply through pharmacy only

Updated on 19 July 2017

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects
  • Change to section 10 - Date of revision of the text

Legal category:Supply through pharmacy only

Free text change information supplied by the pharmaceutical company

In section 4.4, addition of warning regarding metabolic acidosis.
In section 4.8, addition of warning regarding skin reactions.
In section 10 the revision date was updated.

Updated on 19 July 2017

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 4 - possible side effects
  • Change to section 6 - date of revision

Updated on 11 July 2016

Reasons for 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 4.9 - Overdose

Legal category:Supply through pharmacy only

Free text change information supplied by the pharmaceutical company

Update to section 4.2, 4.4 and 4.9 of the SPC.

Updated on 08 July 2016

Reasons for updating

  • Change to warnings or special precautions for use
  • Change of contraindications

Updated on 15 April 2016

Reasons for updating

  • Change to MA holder contact details

Updated on 10 July 2015

Reasons for updating

  • Change to section 7 - Marketing authorisation holder

Legal category:Supply through pharmacy only

Free text change information supplied by the pharmaceutical company

Section 7

Marketing Authorisation Holder address updated to:

12 Riverwalk,

Citywest Business Campus,

Dublin 24,

Ireland

Updated on 08 January 2015

Reasons for updating

  • Change to section 3 - Pharmaceutical form

Legal category:Supply through pharmacy only

Free text change information supplied by the pharmaceutical company

Section 3 Product description updated from off white to pale yellow off white

Updated on 14 November 2014

Reasons for updating

  • Improved electronic presentation

Updated on 08 July 2014

Reasons for updating

  • Change to packaging

Updated on 09 August 2010

Reasons for updating

  • Change to warnings or special precautions for use
  • Change of contraindications
  • Change to instructions about missed dose
  • Change to side-effects
  • Change to further information section
  • Change to date of revision
  • Change to improve clarity and readability
  • Change of special precautions for disposal
  • Change due to user-testing of patient information

Updated on 15 June 2010

Reasons for 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

Legal category:Supply through pharmacy only

Free text change information supplied by the pharmaceutical company

Section 4.2
The following two warnings are added :
Do not take more often than every 4 hours. 
Do not take more than 6 sachets in any 24 hours.

Section 4.4
Warning re: sodium content is added

Section 4.8
Side effect frequencies are added and side effects are presented in the table

Section 4.9
Text re: ascorbic acid is added

Section 10
Date is updated

Updated on 12 August 2008

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 10 - Date of revision of the text

Legal category:Supply through pharmacy only

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 11 July 2008

Reasons for updating

  • Change to improve clarity and readability

Updated on 12 June 2008

Reasons for 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 7 - Marketing authorisation holder
  • Change to section 9 - Date of renewal of authorisation
  • Change to section 10 - Date of revision of the text

Legal category:Supply through pharmacy only

Free text change information supplied by the pharmaceutical company

Sections 1, 2, 5.1, 6.5, 6.6, 9 and 10 updated.

Updated on 14 February 2007

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use

Legal category:Supply through pharmacy only

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 26 October 2006

Reasons for updating

  • New PIL for medicines.ie

Updated on 21 August 2006

Reasons for updating

  • New SPC for new product

Legal category:Supply through pharmacy only