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Boehringer Ingelheim Limited Consumer Healthcare
Ellesfield Avenue, Bracknell, Berkshire, RG12 8YS
Telephone: +44 (0)1344 424 600
Fax: +44 (0)1344 741 399
WWW: http://www.boehringer-ingelheim.co.uk
Medical Information Direct Line: +44 (0)1344 741 286
Medical Information e-mail: medinfo@bra.boehringer-ingelheim.com
Customer Care direct line: +44 (0)1344 741 186
Medical Information Fax: +44 (0)1344 741 298

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: 07/12/2010
SPC Dulcobalance 10 g, powder for oral solution in sachet

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 07/12/2010 and displayed until Current
Reasons for adding or updating:
  • Change to section 1 -Name of the Medicinal product
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.4 - Special warnings and precautions for Use
  • Change to section 4.6 - Pregnancy and Lactation
  • Change to section 4.8 - Undesirable Effects
  • Change to section 6.1 - List of Excipients
  • Change to section 6. 4 - Special Precautions for Storage
  • 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:   01-Nov-2010
Legal Category:   P
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company


Section 1 Name of the Medicinal Product

The product name has been changed to Dulcobalance 10 g, powder for oral solution in sachet i.e. addition of the text after the word Dulcobalance.

 

Section 2 Quantitative and Qualitative Composition

New second and third paragraphs have been added to this section regarding what the product consists of.

 

Section 4.4 Special Warnings and Precautions for Use

A new third paragraph regarding the presence of sulphur dioxide has been added to the Warnings sub-heading of this section.

 

Section 4.6 Pregnancy and Lactation

A new second paragraph has been added to the Pregnancy sub-heading of this section regarding systemic exposure to Dulcobalance.

 

A new paragraph regarding breast-feeding has been added to the Lactation sub-heading of this section.  The previous text under this sub-heading has been deleted.

 

Section 4.8 Undesirable Effects

This section has had all its text replaced, including the tabulation of adverse reactions by system organ class and details of undesirable effects by adult population and paediatric population.

 

Section 6.1 List of Excipients

The text … , BHA (E320) and sulphur dioxide (E220) has been added to the end of the last paragraph of this section.

 

Section 6.4 Special Precautions for Storage

The previous text of No special precaution for storage has been replaced with the text This medicinal product does not require any special storage condition.

 

Section 9 Date of First Authorisation/Renewal of the Authorisation

The date of last renewal details of 05 May 2010 have been added to this section.

 

Section 10 Date of Revision of the Text

The date has been amended to November 2010.
Updated on 11/02/2010 and displayed until 07/12/2010
Reasons for adding or updating:
  • New SPC for new product
Date of revision of text on the SPC:  
Legal Category:   P
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
None provided

Active Ingredients/Generics

 
  macrogol 4000