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Procter & Gamble (Health & Beauty Care) Ltd.
The Heights, Brooklands, Weybridge, Surrey, KT13 0XP, UK
Telephone: +44 (0)191 297 5000
Fax: +44 (0)191 297 6295
WWW: http://www.uk.pg.com
Customer Care direct line: +44 (0) 8000 850367 (UK)
Customer Care direct line: +353 (1) 800 509 301 (Ireland)

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: 01/06/2011
SPC Regulan Lemon/Lime Flavour

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 01/06/2011 and displayed until Current
Reasons for adding or updating:
  • Change to section 4.3 - Contraindications
  • Change to section 4.4 - Special warnings and precautions for Use
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   11-May-2011
Legal Category:   GSL
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company


In Section 4.3 (Contra-indications)
or any of the ingredients and Do not give to children under 6 years of age, unless on the advice of a doctor have been added

In Section 4.4 (Special Warnings)
It is important to take the product with sufficient fluid

If symptoms persist consult your doctor

Keep out of reach and sight of children have all been added

Bed has been changed to sleep

In Section 4.5 (Interactions with other Medicaments)
None has been replaced with There are no known clinical relevant interactions.

In Section 10 (Date of Revision of the Text)
01/08/2009 has been replaced with 11/05/2011
Updated on 19/08/2010 and displayed until 01/06/2011
Reasons for adding or updating:
  • Change to section 6. 5 - Nature and Contents of Container
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   01-Aug-2009
Legal Category:   GSL
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company


In Section 6.5 - aluminium has been removed

In Section 10 - Revision date has been amended to 01/08/2009
Updated on 07/09/2009 and displayed until 19/08/2010
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:   03-Aug-2009
Legal Category:   GSL
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Section 4.8 of the SPC has been updated, please text below:

Gastrointestinal disorders: Gastrointestinal obstruction or impaction

Immune system disorders SOC: Allergy or Hypersensitivity (have been reported with hydrophilic mucilloid preparations).


Gastrointestinal disorders: Regulan (Ispaghula), as with other bulk laxatives, may temporarily increase flatulence and abdominal distension when the product is first used. Other symptoms including nausea, diarrhoea and abdominal discomfort or pain have rarely been reported (<1 in 1000).

Intestinal obstruction and faecal impaction may occur very rarely (<1 in 10,000), especially if the product is taken with insufficient fluid.

Immune system disorders SOC: There are very rare reports (<1 in 10,000) of allergic or hypersensitivity reactions associated with the ingestion or inhalation of Ispaghula including skin rashes or allergic dermatitis, rhinitis, urticaria, bronchospasm and anaphylactic reactions.

Section 10 of the SPC has been updated, please text below:

January 2006

June 2009
Updated on 25/10/2006 and displayed until 07/09/2009
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:   01/2006
Legal Category:   GSL
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Licence renewal, minor changes to text.
 
Addition of the following to Section 4.8:
Immune system disorders SOC:  Allergy or Hypersensitivity (have been reported with hydrophilic mucilloid preparations).
Updated on 09/08/2004 and displayed until 25/10/2006
Reasons for adding or updating:
  • Change to section 5.3 - Preclinical Safety Data
Updated on 25/07/2001 and displayed until 09/08/2004
Reasons for adding or updating:
  • No reasons supplied
Updated on 24/11/2000 and displayed until 25/07/2001
Reasons for adding or updating:
  • No reasons supplied

Active Ingredients/Generics

 
  ispaghula husk