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: 18/10/2011
SPC Beechams All-in-One

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 18/10/2011 and displayed until Current
Reasons for adding or updating:
  • Change to section 4.2 - Posology and method of administration
Date of revision of text on the SPC:   14-Oct-2011
Legal Category:   GSL
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company

Section 4.2 - Maximum duration of use amended to 5 days.
Updated on 02/09/2010 and displayed until 18/10/2011
Reasons for adding or updating:
  • 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 4.7 - Effects on Ability to Drive and Use Machines
  • 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:   01-Jul-2010
Legal Category:   GSL
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company



Section 4.3 – Contra-indications to concomitant use of other sympathomimetic decongestants, phaeochromosytoma and closed angle glaucoma added.

Section 4.4 – Special warnings and precautions added for enlarged prostate gland, occlusive vascular disease and cardiovascular disease.  Addition of advice to consult a physician before taking if suffering from chronic cough or asthma, or if cough lasts more than 5 days, comes back, or is accompanied by a fever, rash or persistent headache.

Addition of alcohol warning.

Section 4.5 – Addition of table detailing nature of drug interactions.

Section 4.7  - Addition of warning not to drive or operate machinery if affected by dizziness.

Section 4.8 – Addition of table listing undesirable effects by ingredient and body system.

Section 4.9 – Revision of section relating to phenylephrine and addition of section relating to guaifenesin.

Section 10  - New revision date

Updated on 20/04/2007 and displayed until 02/09/2010
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 4.9 - Overdose
  • Change to section 6.1 - List of Excipients
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   03/2007
Legal Category:   GSL
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company

Section 4.4 Addition of statement regarding sorbitol content
Section 4.5 Update BAN cholestyramine to rINN colestyramine
Section 4.9 Update to include generic overdose statements for paracetamol and phenylephrine
Section 6.1 Update to bring excipients list in line with EC guidelines
 
Updated on 12/05/2005 and displayed until 20/04/2007
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

 
   paracetamol
   phenylephrine hydrochloride
   guaifenesin