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

Nycomed UK Ltd
Nycomed UK Ltd, 3 Globeside Business Park, Fieldhouse Lane, MARLOW, Buckinghamshire, SL7 1HZ, UK
Telephone: +44 (0)1628 646 400
Fax: +44 (0)1628 646 401
WWW: http://www.nycomed.com
Medical Information Direct Line: +44 (0) 800 633 5797
Medical Information e-mail: medinfo@nycomed.com
Medical Information Fax: +44 (0)1628 646 534

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: 25/01/2012
SPC Protium 40 mg i.v. Powder for Solution for 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 25/01/2012 and displayed until Current
Reasons for adding or updating:
  • Change to section 4.8 - Undesirable Effects
Date of revision of text on the SPC:   20-Dec-2011
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company


To update Section 4.8 of the SPC by adding the following adverse drug  reactions:

Agranulocytosis, Pancytopenia, Hypomagnesaemia and Taste disorders. In addition editorial updates have been made following request by IE at the end of the renewal procedure.
Updated on 06/09/2010 and displayed until 25/01/2012
Reasons for adding or updating:
  • Change due to harmonisation of SPC
Date of revision of text on the SPC:   31-Aug-2010
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company


Change to the Summary of Product Characteristics following a procedure in accordance with Article 30 of Directive 2001/83/EC (referral procedure).  The SmPC has been harmonised with the other Pantoprazole products in the range. 

 
Updated on 04/02/2008 and displayed until 06/09/2010
Reasons for adding or updating:
  • Change to section 7 - Marketing Authorisation Holder
  • Change to section 8 - MARKETING AUTHORISATION NUMBER(S)
  • Change to section 10 date of revision of the text
  • Company name change or merger
  • Change to MA holder contact details
Date of revision of text on the SPC:   01/2008
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company

Section 7: Change in name of MAH from ALTANA Pharma AG to Nycomed GmbH.

Section 8: New PL number to relfect change in MAH.

Section 10: Updated to reflect approval of change of ownership application.
Updated on 29/11/2007 and displayed until 04/02/2008
Reasons for adding or updating:
  • Change to section 4.2 - Posology and method of administration
  • Change to section 5.2 - Pharmacokinetic Properties
Date of revision of text on the SPC:   11/2007
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company

Section 4.2 - revision of text refering to recommedation for use in children.

Section 5.2 - inclusion of PK data from children.
Updated on 15/08/2007 and displayed until 29/11/2007
Reasons for adding or updating:
  • Change to section 4.3 - Contraindications
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 4.8 - Undesirable Effects
  • Change to section 6. 3 - Shelf Life
Date of revision of text on the SPC:   06/2007
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Section 4.3  The addition of the co-administration of pantoprazole with atazanavir as a contraindication
Section 4.5 The addition of a possible interaction with the co-administration of pantoprazole with atazanavir
Section 4.8 The addtion of depression, hallucination, disorientation and confusion as rare side effects
Section 6.3 Shelf life changed to 2 years.
Updated on 25/10/2006 and displayed until 15/08/2007
Reasons for adding or updating:
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
Date of revision of text on the SPC:   12/2005
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Section 4.5 changed
From :The response to anticoagulants such as warfarin, phenprocoumon or acenocoumarol may be affected by any concomitant medication.  It is therefore good practice to monitor the patient with additional PT (Prothrombin time)/INR (International Normalized Ratio) determinations when Protium (strength) is initiated, discontinued
 
TO:Although no interaction during concomitant administration of phenprocoumon or warfarin has been observed in clinical pharmacokinetic studies, a few isolated cases of changes in INR have been reported during concomitant treatment in the post-marketing period.  Therefore, in patients treated with coumarin anticoagulants, monitoring of prothrombin time/INR is recommended after initiation, termination or during irregular use of pantoprazole.
Updated on 10/07/2006 and displayed until 25/10/2006
Reasons for adding or updating:
  • Change to section 4.5 - Interactions with other Medicaments and other forms of Interaction
  • Change to section 4.8 - Undesirable Effects
  • Change to section 10 (date of (partial) revision of the text
Date of revision of text on the SPC:   12/2005
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
4.5            Interactions with other Medicaments and other forms of Interaction
The following statement has been added: The response to anticoagulants such as warfarin, phenprocoumon or acenocoumarol may be affected by any concomitant medication
 
 
4.8            Undesirable Effects
 
The following have been added to this section: Leukopenia: Thrombocytopenia, Dry mouth, Arthralgia, Vomiting
Updated on 29/07/2005 and displayed until 10/07/2006
Reasons for adding or updating:
  • Change to section 6.1 - List of Excipients
Updated on 28/09/2004 and displayed until 29/07/2005
Reasons for adding or updating:
  • Correction of spelling/typing errors
Updated on 28/09/2004 and displayed until 28/09/2004
Reasons for adding or updating:
  • Correction of spelling/typing errors
Updated on 28/09/2004 and displayed until 28/09/2004
Reasons for adding or updating:
  • Correction of spelling/typing errors
Updated on 17/08/2004 and displayed until 28/09/2004
Reasons for adding or updating:
  • Correction of spelling/typing errors
Updated on 17/08/2004 and displayed until 17/08/2004
Reasons for adding or updating:
  • Correction of spelling/typing errors
Updated on 17/08/2004 and displayed until 17/08/2004
Reasons for adding or updating:
  • Correction of spelling/typing errors
Updated on 17/08/2004 and displayed until 17/08/2004
Reasons for adding or updating:
  • Correction of spelling/typing errors
Updated on 18/02/2004 and displayed until 17/08/2004
Reasons for adding or updating:
  • Improved Electronic Presentation
Updated on 18/02/2004 and displayed until 18/02/2004
Reasons for adding or updating:
  • Improved Electronic Presentation
Updated on 07/10/2003 and displayed until 18/02/2004
Reasons for adding or updating:
  • Improved Electronic Presentation
Updated on 25/09/2003 and displayed until 07/10/2003
Reasons for adding or updating:
  • New SPC for eMC ie an SPC for an existing product, but one that is new for the eMC
Updated on 24/09/2003 and displayed until 25/09/2003
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

 
  pantoprazole sodium sesquihydrate