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hameln pharmaceuticals ltd

Nexus, Gloucester Business Park, Gloucester, GL3 4AG
Telephone: +44 (0)1452 621 661
Fax: +44 (0)1452 632 732
WWW: http://www.hameln.co.uk
Medical Information e-mail: drugsafety@hameln.co.uk

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: 04/01/2012
SPC Metoclopramide 5 mg/ml Injection

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 04/01/2012 and displayed until Current
Reasons for adding or updating:
  • Change to section 4.1 - Therapeutic indications
  • 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 4.8 - Undesirable Effects
  • Change to section 4.9 - Overdose
Date of revision of text on the SPC:   30-Dec-2011
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company



The SPC has been updated with information in line with the recommendations of a Paediatric Assessment Report for Metoclopramide following a European work-sharing procedure.

Updated sections of the SmPC  include Sections 4.1, 4.2, 4.3, 4.4, 4.8 and 4.9.

Updated on 22/02/2011 and displayed until 04/01/2012
Reasons for adding or updating:
  • Change to section 6. 3 - Shelf Life
Date of revision of text on the SPC:   09-Feb-2011
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company

Change to section 6.3 - the shelf life has been changed from 24 months to 36 months.
Updated on 14/01/2009 and displayed until 22/02/2011
Reasons for adding or updating:
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 4.8 - Undesirable Effects
Date of revision of text on the SPC:   15-Dec-2008
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company

Section 4.5 has been updated to advise that “Metoclopramide may increase the absorption of ciclosporin and raise its blood levels”.

Section 4.8 has been updated to advise that “Transient hypotension followed by compensatory tachycardia may occur”.

 

           

Updated on 09/06/2008 and displayed until 14/01/2009
Reasons for adding or updating:
  • New SPC for eMC ie an SPC for an existing product, but one that is new for the eMC
Date of revision of text on the SPC:  
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company

None provided

Active Ingredients/Generics

 
   metoclopramide hydrochloride