Last Updated on eMC 14-10-2016 View medicine  | Norgine Limited Contact details

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.

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 4.4 - Special warnings and precautions for use
  • Change to section 4.6 - Fertility, pregnancy and lactation
  • Change to section 4.7 - Effects on ability to drive and use machines
  • Change to section 4.8 - Undesirable effects
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 5.2 - Pharmacokinetic properties
  • Change to section 6.4 - Special precautions for storage
  • Change to section 10 - Date of revision of the text

Date of revision of text on the SPC:04-10-2016

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:



The following changes have been made:

Section 2.

Added to list Lactose as an excipient with known effect.

Section 4.2

Updated to align with QRD Template.

Section 4.3

Updated to align with QRD Template.

Section 4.4

Addition of warning regarding galactose intolerance.

Section 4.6

Addition of extra information detailing use in pregnancy and lactation,  updated to align with QRD Template.

Section 4.7

Updated to align with QRD Template.

Section 4.8

Addition of adverse event reporting details, and align with QRD Template.

Section 5.1

Updated to align with QRD Template.

Section 5.2

Updated to align with QRD Template.

Section 6.4

Addition of storage conditions information

Section 10

Revision date updated

 

 

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:16-12-2010

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.

Reasons for adding or updating:

  • Correction of spelling/typing errors

Date of revision of text on the SPC:22-08-2002

Legal Category:POM

Black Triangle (CHM): NO

Reasons for adding or updating:

  • Change to section 4.2 - Posology and method of administration

Date of revision of text on the SPC:01-01-2009

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

 

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

Reasons for adding or updating:

  • Improved Electronic Presentation

Reasons for adding or updating:

  • Change to section 3 - pharmaceutical form

Reasons for adding or updating:

  • No reasons supplied