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Bracco UK Limited

Bracco House, Mercury Park, Wycombe Lane, Wooburn Green, High Wycombe, Bucks, HP10 0HH
Telephone: +44 (0)1628 851 500
Fax: +44 (0)1628 819 317

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: 03/02/2012
SPC Gastromiro

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 03/02/2012 and displayed until Current
Reasons for adding or updating:
  • Change to section 4.8 - Undesirable Effects
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   16-Jan-2012
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
SECTION 4.8

Additional text:

Anaphylactoid reactions/hypersensitivity may manifest with: mild localized or more diffuse angioneurotic oedema, tongue oedema, laryngospasm or laryngeal oedema, dysphagia, pharyngitis and throat tightness, pharyngolaryngeal pain, cough, conjunctivitis, rhinitis, sneezing, feeling hot, sweating increased, asthenia, dizziness, pallor, dyspnoea, wheezing, bronchospasm, and moderate hypotension. Skin reactions may occur in the form of various types of rash, diffuse erythema, diffuse blisters, urticaria, and pruritus. These reactions, which occur irrespective of the dose administered and the route of administration, may represent the first signs of incipient state of shock. Administration of the contrast medium must be discontinued immediately and – if necessary – specific treatment initiated via a venous access.

More severe reactions involving the cardiovascular system such as vasodilatation with pronounced hypotension, tachycardia, dyspnoea, agitation, cyanosis and loss of consciousness (syncope) may require emergency treatment.

Paediatric population

No anaphylactoid reaction has been reported in children after oral or rectal administration of iopamidol however they have been reports of such reactions after parenteral administration of iopamidol.

 

 

 

SECTION 10

Date of Revision 16 January 2012
Updated on 27/09/2006 and displayed until 03/02/2012
Reasons for adding or updating:
  • Correction of spelling/typing errors
Updated on 26/09/2006 and displayed until 27/09/2006
Reasons for adding or updating:
  • Change to section 6. 5 - Nature and Contents of Container
  • Change to section 6. 6 - Instructions for use, handling and disposal
  • Change to section 9 - Date of first Authorisation/renewal of the Authorisation
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   09/2006
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
6.5. nature and contents of container changed to 6.5 nature and contents of container
6.6 instructions for use / handling changed to 6.6 instructions for use,handling and disposal
9. date of first authorisation/renewal of authorisation changed to 9. date of first authorisation/renewal of the authorisation
10. date of (partial) revision of the text changed to 10. date of revision of the text
Updated on 26/09/2006 and displayed until 26/09/2006
Reasons for adding or updating:
  • Correction of spelling/typing errors
Updated on 21/09/2006 and displayed until 26/09/2006
Reasons for adding or updating:
  • Change to section 10 (date of (partial) revision of the text
Date of revision of text on the SPC:   09/2006
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
NAME OF THE MEDICINAL PRODUCT CHANGED TO 1.NAME OF THE MEDICINAL PRODUCT
Updated on 21/09/2006 and displayed until 21/09/2006
Reasons for adding or updating:
  • Correction of spelling/typing errors
Updated on 21/09/2006 and displayed until 21/09/2006
Reasons for adding or updating:
  • Change to section 10 (date of (partial) revision of the text
Date of revision of text on the SPC:   09/2006
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
NAME OF MEDICINAL PRODUCT CHANGED TO READ NAME OF THE MEDICINAL PRODUCT
Updated on 21/09/2006 and displayed until 21/09/2006
Reasons for adding or updating:
  • Change to section 10 (date of (partial) revision of the text
Date of revision of text on the SPC:   09/2006
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
4.5 Interactions changed to interaction
6.1 Excipients changed to read List of Excipients
6.5 space removed between of container
8. Number changed to NUMBER(S)
Updated on 21/09/2006 and displayed until 21/09/2006
Reasons for adding or updating:
  • Change to section 7 - Marketing Authorisation Holder
  • Change to section 10 (date of (partial) revision of the text
Date of revision of text on the SPC:   07/2002
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
 

Change to section 7 - Marketing Authorisation Holder,

Change to section 10 date of revision of the text
Updated on 06/09/2006 and displayed until 21/09/2006
Reasons for adding or updating:
  • Change to section 7 - Marketing Authorisation Holder
  • Change to section 10 (date of (partial) revision of the text
Date of revision of text on the SPC:   03/2002
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
 

Change to section 7 - Bracco UK Limited 

Change to section 10  - 7th March 2002
Updated on 04/09/2006 and displayed until 06/09/2006
Reasons for adding or updating:
  • Change to section 7 - Marketing Authorisation Holder
Date of revision of text on the SPC:   07/2002
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
 

Change to section 7 - Marketing Authorisation Holder,

Change to section 10 (date of (partial) revision of the text
Updated on 01/09/2006 and displayed until 04/09/2006
Reasons for adding or updating:
  • Change to section 7 - Marketing Authorisation Holder
  • Change to section 10 (date of (partial) revision of the text
Date of revision of text on the SPC:   07/2002
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Section 7: Bracco UK Ltd, Bracco House, Mercury Park, Wycombe Lane, Wooburn Green, Buckinghamshire, HP10 0HH
 
Section 8: PL18920/0012
 
Section 10: 7th March 2002
Updated on 02/08/2001 and displayed until 01/09/2006
Reasons for adding or updating:
  • Correction of spelling/typing errors
Updated on 02/07/2001 and displayed until 02/08/2001
Reasons for adding or updating:
  • No reasons supplied
Updated on 06/09/1999 and displayed until 02/07/2001
Reasons for adding or updating:
  • No reasons supplied

Active Ingredients/Generics

 
  iopamidol