GlaxoSmithKline Consumer Healthcare

980 Great West Road, Brentford, Middlesex, TW8 9GS
Telephone: +44 (0)20 8047 5000
Medical Information Direct Line: +44 (0)20 8047 2500
Medical Information e-mail: customer.relations@gsk.com
Customer Care direct line: +44 (0)20 8047 2700
Medical Information Fax: +44 (0)20 8047 6860

Summary of Product Characteristics last updated on the eMC: 28/05/2010
SPC Piriton Allergy Tablets

When a pharmaceutical company changes an SPC or PIL, a new version is published on the eMC. For each version, we show the dates it was published on the eMC and the reasons for change.

Updated on 28/05/2010 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 4.6 - Pregnancy and Lactation
  • Change to section 4.8 - Undesirable Effects
  • Change to section 4.9 - Overdose
  • Change to section 5.1 - Pharmacodynamic Properties
Date of revision of text on the SPC:   24-May-2010
Legal Category:   P
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company

Section 4.2 - addition of dosage restrictions for elderly patients
Section 4.4 - addition of warning to avoid use with other antihistamines, and warning re: fructose intolerance etc.
Section 4.5 - addition of recommendation to seek medical advice before taking chlorphenamine concurrently with hypnotics or anxiolytics
Section 4.6 - advice revised to not use during pregnancy and lactation unless considered essential by a physician
Section 4.8 - section reformatted and information on frequency of events added
Section 4.9 - removal of advice to use gastric lavage and induced emesis to treat overdose, and that treatment should be given within an hour of ingestion
Section 5.1 - addition of ATC code and revision of pharmacodynamic effects
Updated on 29/11/2007 and displayed until 28/05/2010
Reasons for adding or updating:
  • Change to section 6. 5 - Nature and Contents of Container
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   11/2007
Legal Category:   P
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company

Section 6.5 - Addition of pack size of 60
Section 10 - updated to November 2007
Updated on 19/05/2005 and displayed until 29/11/2007
Reasons for adding or updating:
  • New SPC for eMC ie an SPC for an existing product, but one that is new for the eMC

Active Ingredients/Generics

 
   chlorphenamine maleate