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Abbott Healthcare Products Limited
2.1 Woodford Business Park, Santry, Dublin 9, Ireland
Telephone: +353 1 8468793
Fax: +353 1 8468701
Medical Information Direct Line: +44 (0)2380 467 000
Medical Information e-mail: medinfo.shl@abbott.com
Medical Information Facsimile: +44 (0)2380 467052
Summary of Product Characteristics last updated on medicines.ie: 05/04/2011
SPC Duphalac 3.335 g / 5 ml Oral Solution

When a pharmaceutical company changes an SPC or PIL, a new version is published on medicines.ie. For each version, we show the dates it was published on medicines.ie and the reasons for change.

Updated on 05/04/2011 and displayed until Current
Reasons for adding or updating:
  • Change to section 7 - Marketing authorisation holder
  • Change to section 10 - Date of revision of the text
Date of revision of text on the SPC:   01-Apr-2011
Legal Category:   Supply through pharmacy only

Free-text change information supplied by the pharmaceutical company


The following section has been updated as highlighted;

 

 

Section 7

 

Abbott Healthcare Products Limited

Mansbridge Road

West End

Southampton 

SO18 3JD

UK

 
Updated on 09/11/2009 and displayed until 05/04/2011
Reasons for adding or updating:
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 6.1 - List of excipients
  • Change to section 6.5 - Nature and contents of container
  • Change to section 9 - Date of renewal of authorisation
Date of revision of text on the SPC:   23-Aug-2009
Legal Category:   Supply through pharmacy only

Free-text change information supplied by the pharmaceutical company
The following sections of the SPC have been revised;


Section 2:

From:

Lactulose solution containing 3.335 g of lactulose per 5 ml.

For excipients, see 6.1

To:

Lactulose solution containing 3.335 g of lactulose per 5 ml.

 

 For a full list of excipients, see section 6.1


Section 6.1:

From:

Purified water.

Duphalac may also contain small amounts of lactose, galactose, epilactose, hydrogen peroxide and sodium hydroxide.

To:

Purified Water

Section 6.5:

From:

Opaque white multidose bottles of HDPE with a polypropylene screw cap containing 300ml or 1 litre.

To:

Opaque white multidose bottles of HDPE with a polypropylene screw cap containing 300ml or 1 litre.

 

Not all pack sizes may be marketed


Section 9:

From:

1 April 1993/ 1 April 2003

To:

Date of first authorisation: 01 April 1983

 

Date of last renewal: 01 April 2008
Updated on 29/06/2006 and displayed until 09/11/2009
Reasons for adding or updating:
  • Change to section 1 - Name of medicinal product
Date of revision of text on the SPC:   06/2006
Legal Category:   retail sale through pharmacy only

Free-text change information supplied by the pharmaceutical company
Section 1. Name of Medicinal Product
 
Changed from Duphalac Solution to Duphalac 3.335g/5ml Oral Solution
Updated on 31/08/2004 and displayed until 29/06/2006
Reasons for adding or updating:
  • Change to section 1 - Name of medicinal product
  • Change to section 2 - Qualitative and quantitative composition
Updated on 05/05/2004 and displayed until 31/08/2004
Reasons for adding or updating:
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.3 - Contraindications
  • Change to section 4.8 - Undesirable effects
Updated on 24/06/2003 and displayed until 05/05/2004
Reasons for adding or updating:
  • New SPC for new product

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Active Ingredients

 
  Lactulose