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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: 18/04/2011
SPC Motilium 30 mg suppositories

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 18/04/2011 and displayed until Current
Reasons for adding or updating:
  • Change to section 5.3 - Preclinical Safety Data
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 vitro experiments on isolated cells transfected with HERG and on isolated guinea pig myocytes, exposure ratios ranged between 5 and 30-foldwere about 10, 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 17/09/2009 and displayed until 18/04/2011
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 to section 4.8 (underlined)

Immune System Disorder: Very rare; anaphylactic reactions including anaphylactic shock, angioneurotic oedema

Psychiatric System Disorder:  Very rare; agitation, nervousness

Nervous system disorders:  Very rare; convulsions, somnolence, headache
 
Skin and subcutaneous tissue disorders:  Very rare; urticaria, pruritus, rash

Investigations:  Very rare; liver function test abnormal  

Other central nervous system-related effects of convulsion, agitation and somnolence also are very rare and primarily reported in infants and children.
Updated on 09/01/2009 and displayed until 17/09/2009
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 24/09/2008 and displayed until 09/01/2009
Reasons for adding or updating:
  • Change to section 4.4 - Special warnings and precautions for Use
  • Change to section 5.3 - Preclinical Safety Data
  • Change to section 6. 3 - Shelf Life
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
Date of revision of text on the SPC:   02-Jul-2007
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company

Completely updated version of SmPC reflecting changes to sections 4.4, 4.5, 5.3 and 6.3 as well as change in MAH.
Updated on 17/09/2004 and displayed until 24/09/2008
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:
  • New SPC for eMC ie an SPC for an existing product, but one that is new for the eMC

Active Ingredients/Generics

 
  domperidone