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DDD Limited
94 Rickmansworth Road, Watford, Hertfordshire, WD18 7JJ
Telephone: +44 1923 22 9251
Fax: +44 1923 22 0728
WWW: http://www.dddgroup.co.uk
Medical Information Direct Line: +44 1923 22 9251
Medical Information Direct Line: +44 7977989686
Medical Information e-mail: info@dentinox.co.uk
Customer Care direct line: +44 1923 22 9251
Medical Information Fax: +44 1923 220 728

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: 31/03/2011
SPC Pulmo Bailly

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 31/03/2011 and displayed until Current
Reasons for adding or updating:
  • Change to section 4.1 - Therapeutic indications
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.4 - Special warnings and precautions for Use
  • Change to section 4.6 - Pregnancy and Lactation
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   01-Feb-2011
Legal Category:   P
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Section 4.1, 4.2, 4.4, and4.6 of the SPC has been updated in line with CHM recommended wording for theuse of codeine in children and breast feeding mothers. $0Pulmo Bailly is not recommended for the treatment of children under the age of 18 years. 
Updated on 04/11/2010 and displayed until 31/03/2011
Reasons for adding or updating:
  • Change to section 4.8 - Undesirable Effects
Date of revision of text on the SPC:   03-Nov-2010
Legal Category:   P
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company


To update section 4.8 (Undesirable effects) of the SPC to include pancreatitis, drug dependence and withdrawal symptoms as proposed in the PSUR.
Updated on 15/02/2010 and displayed until 04/11/2010
Reasons for adding or updating:
  • Change to section 4.6 - Pregnancy and Lactation
Date of revision of text on the SPC:   10-Feb-2010
Legal Category:   P
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company

Section 4.6 updated to include the potential risk of gastric stasis and inhalation pneumonia when used in labour.
Updated on 28/01/2010 and displayed until 15/02/2010
Reasons for adding or updating:
  • Change to section 4.3 - Contraindications
Date of revision of text on the SPC:   26-Jan-2010
Legal Category:   P
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company


Update section 4.3 (Contraindications) of the SPC to bring in line with European guidelines on labelling for excipients.

New text introduced:

 

Contains sucrose. Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine.
Updated on 29/09/2009 and displayed until 28/01/2010
Reasons for adding or updating:
  • Correction of spelling/typing errors
Date of revision of text on the SPC:   14-Jul-2009
Legal Category:   P
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
None provided
Updated on 30/07/2009 and displayed until 29/09/2009
Reasons for adding or updating:
  • New SPC for eMC ie an SPC for an existing product, but one that is new for the eMC
Date of revision of text on the SPC:  
Legal Category:   GSL
Black Triangle (CHM):   NO

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

Active Ingredients/Generics

 
  guaiacol
  codeine