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Norgine Limited
Norgine House, Widewater Place, Moorhall Road, Harefield, Middlesex, UB9 6NS
Telephone: +44 (0)1895 826 600
Fax: +44 (0)1895 825 865
E-mail:
Medical Information e-mail: medinfo@norgine.com

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: 22/12/2010
SPC DESTOLIT 150 mg tablets

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 22/12/2010 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 4.6 - Pregnancy and Lactation
  • Change to section 4.8 - Undesirable Effects
Date of revision of text on the SPC:   16-Dec-2010
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Sections updated to be inline with the Core Safety Profile.
Updated on 22/10/2010 and displayed until 22/12/2010
Reasons for adding or updating:
  • Correction of spelling/typing errors
Date of revision of text on the SPC:   22-Aug-2002
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
None provided
Updated on 31/03/2009 and displayed until 22/10/2010
Reasons for adding or updating:
  • Change to section 4.2 - Posology and method of administration
Date of revision of text on the SPC:   01-Jan-2009
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company


4.2       Posology and method of administration

 

Adults and the elderly

Dissolution of gallstones:

A daily dose of 8 to 12mg/kg UDCA will produce cholesterol desaturation in the majority of cases. The measurement of the lithogenic index on bile-rich duodenal drainage fluid after 4-6 weeks of therapy may be useful for determining the minimum effective dose. The lowest effective dose has been found to be 4 mg/kg. The daily dose for most patients is 3 or 4 tablets, according to body weight. The dose should be divided into two administrations after meals, with one administration always after the evening meal.

The duration of treatment needed to achieve dissolution will not usually exceed 2 years, and should be monitored with regular cholecystograms. Treatment should be continued for 3-4 months after the radiological disappearance of gallstones.

Any temporary discontinuation of treatment, if prolonged for 3-4 weeks, will allow the bile to return to a state of supersaturation, and will extend the total time taken for litholysis. In some cases stones may recur after successful treatment.

 

Children and adolescents                                          

 

Not recommended.

 

For oral administration.

4.2       DATE OF REVISION OF THE TEXT

 

11TH Jen 2005      January 2009

 
Updated on 14/07/2005 and displayed until 31/03/2009
Reasons for adding or updating:
  • Change to section 4.2 - Posology and Method of Administration
  • Change to section 4.3 - Contra-indications
  • Change to section 4.5 - Interactions with other Medicaments and other forms of Interaction
  • Change to section 4.6 - Pregnancy and Lactation
  • Change to section 4.8 - Undesirable Effects
  • Change to section 10 (date of (partial) revision of the text
Updated on 22/09/2003 and displayed until 14/07/2005
Reasons for adding or updating:
  • Improved Electronic Presentation
Updated on 13/08/2001 and displayed until 22/09/2003
Reasons for adding or updating:
  • Change to section 3 - pharmaceutical form
Updated on 06/09/1999 and displayed until 13/08/2001
Reasons for adding or updating:
  • No reasons supplied

Active Ingredients/Generics

 
  ursodeoxycholic acid