Home | About the eMC | Help | Mobile
eMC - trusted, up to date and comprehensive information about medicines
Link to eMC medicine guides website
eMC homepage
Advanced search
Get Medicines Compendium UK app here

Winthrop Pharmaceuticals UK Ltd
One Onslow Street, Guildford, Surrey, GU1 4YS, UK
Telephone: +44 (0)1483 505 515
Fax: +44 (0)1483 554 831
E-mail: UK-medicalinformation@sanofi-aventis.com
Medical Information Direct Line: +44 (0)1483 554 101
Medical Information Fax: +44 (0)1483 554 831

Before you contact this company: often several companies will market medicines with the same active ingredient. Please check that this is the correct company before contacting them. Why?
Summary of Product Characteristics last updated on the eMC: 19/04/2011
SPC Domperidone 10mg Film-coated 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 19/04/2011 and displayed until Current
Reasons for adding or updating:
  • Change to section 5.3 - Preclinical Safety Data
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   30-Mar-2011
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Section 5.3 Preclinical Safety Data

In in vitroexperiments on isolated cells transfected with HERG and on isolated guinea

pig myocytes, exposure ratios were about 10 ranged between 5 and 30-fold,

based on IC50 values inhibiting currents through IKr ion channels in

comparison to the free plasma concentrations in humans after administration

of the maximum daily dose of 20mg (q.i.d.). Exposure margins for

prolongation of action potential duration in in vitro experiments on isolated

cardiac tissues exceeded the free plasma concentrations in humans at

maximum daily dose (20mg q.i.d) by 17-fold. However, safety margins in in

vitro experiments on isolated cardiac tissues pro-arrhythmic models (isolated

Langendorff perfused heart) and in in vivo models (dog, guinea pig, rabbits

sensitised for torsades de pointes) exceeded the free plasma concentrations in

humans at maximum daily dose (20mg q.i.d.) by more than 5017-fold. In the

presence of inhibition of the metabolism via CYP3A4 free plasma

concentrations of domperidone can rise up to 10-fold.
Updated on 16/09/2009 and displayed until 19/04/2011
Reasons for adding or updating:
  • Change to section 4.8 - Undesirable Effects
Date of revision of text on the SPC:   29-Jan-2009
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Added:

Cardiac disorders:

Very rare; ventricular arrhythmias,

Frequency not known: QTc prolongation
Updated on 09/01/2009 and displayed until 16/09/2009
Reasons for adding or updating:
  • Change to section 4.4 - Special warnings and precautions for Use
  • Change to section 4.9 - Overdose
Date of revision of text on the SPC:   10-Dec-2008
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Section 4.4 - update to Cardiovascular warnings
Section 4.9 - updated in line with Company Core Safety Data
Updated on 23/09/2008 and displayed until 09/01/2009
Reasons for adding or updating:
  • Change to section 7 - Marketing Authorisation Holder
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   10-Aug-2007
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Change of MAH to Winthrop Pharmaceuticals (part of Sanofi-aventis group of companies)
Updated on 17/09/2004 and displayed until 23/09/2008
Reasons for adding or updating:
  • Change to section 4.4 - Special Warnings and Precautions for Use
  • Change to section 4.5 - Interactions with other Medicaments and other forms of Interaction
  • Change to section 5.3 - Preclinical Safety Data
  • Change to section 10 (date of (partial) revision of the text
Updated on 12/09/2003 and displayed until 17/09/2004
Reasons for adding or updating:
  • Change to section 1 - trade name
  • Change to section 2 - qualitative and quantitative composition
  • Change to section 3 - pharmaceutical form
  • Change to section 4.1 - Therapeutic Indications
  • Change to section 4.2 - Posology and Method of Administration
  • Change to section 4.3 - Contra-indications
  • Change to section 4.4 - Special Warnings and Precautions for Use
  • Change to section 4.5 - Interactions with other Medicaments and other forms of Interaction
  • Change to section 4.6 - Pregnancy and Lactation
  • Change to section 4.7 - Effects on Ability to Drive and Use Machines
  • Change to section 4.9 - Overdose
  • Change to section 5.1 - Pharmacodynamic Properties
  • Change to section 5.2 - Pharmacokinetic Properties
  • Change to section 6.1 - List of Excipients
  • Change to section 6.2 - Incompatibilities
  • Change to section 6. 3 - Shelf Life
  • Change to section 6. 4 - Special Precautions for Storage
  • Change to section 6. 6 - Instruction for Use/Handling
Updated on 26/09/2002 and displayed until 12/09/2003
Reasons for adding or updating:
  • Change to section 10 (date of (partial) revision of the text
Updated on 20/08/2001 and displayed until 26/09/2002
Reasons for adding or updating:
  • Change to section 7 - Marketing Authorisation Holder

Active Ingredients/Generics

 
  domperidone maleate