Home | About the eMC | Help | Mobile
eMC - trusted, up to date and comprehensive information about medicines
Link to eMC medicine guides website
eMC homepage
Advanced search
Get Medicines Compendium UK app here

Ferring Pharmaceuticals Ltd
Drayton Hall, Church Road, West Drayton, UB7 7PS, UK
Telephone: +44 (0)844 931 0050
Fax: +44 (0)844 931 0051
WWW: http://www.ferring.co.uk
Medical Information Direct Line: +44 (0)844 931 0054
Medical Information e-mail: medical@ferring.com
Medical Information Fax: +44 (0)844 931 0051

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: 06/10/2010
SPC Pentasa Sachet 1g

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 06/10/2010 and displayed until Current
Reasons for adding or updating:
  • Change to section 3 - Pharmaceutical form
  • Change to section 6.1 - List of Excipients
Date of revision of text on the SPC:   07-Apr-2010
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
In section 3 - colour of the granules has changed to;  White-grey to pale white-brown granules

In section 6.1: Microcrystalline Cellulose excipient replaced with Povidone
Updated on 11/05/2010 and displayed until 06/10/2010
Reasons for adding or updating:
  • Change to section 4.2 - Posology and method of administration
Date of revision of text on the SPC:   07-Apr-2010
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company


Addition of Paediatric use.

4.2       Posology and method of administration

 

Ulcerative colitis

 

Paediatric population:

There is only limited documentation for an effect in children (age 6-18 years).

 

Children 6 years of age and older:

Active disease: To be determined individually, starting with 30-50 mg/kg/day in divided doses. Maximum dose: 75 mg/kg/day in divided doses. The total dose should not exceed 4 g/day (maximum adult dose).

Maintenance treatment: To be determined individually, starting with 15-30 mg/kg/day in divided doses. The total dose should not exceed 2 g/day (recommended adult dose).

 

It is generally recommended that half the adult dose may be given to children up to a body weight of 40 kg; and the normal adult dose to those above 40 kg.

Updated on 09/01/2009 and displayed until 11/05/2010
Reasons for adding or updating:
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.2 - Posology and method of administration
Date of revision of text on the SPC:   10-Dec-2008
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Section 2.: added the following "For a full list of excipients, see section 6.1."

Section 4.2: amended the dosing for maintenance treatment to once daily;

Maintenance treatment

Individual dosage. Recommended dosage, 2 g mesalazine once daily.

Updated on 04/08/2008 and displayed until 09/01/2009
Reasons for adding or updating:
  • Change to section 6. 5 - Nature and Contents of Container
Date of revision of text on the SPC:   07-Mar-2008
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Section 6.5 - Addition of new pack sizes: 100 sachets or 150 sachets
Updated on 31/03/2008 and displayed until 04/08/2008
Reasons for adding or updating:
  • Change to section 2 - Qualitative and quantitative composition
  • 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 4.8 - Undesirable Effects
  • Change to section 5.1 - Pharmacodynamic Properties
  • Change to section 6. 4 - Special Precautions for Storage
  • Change to section 6. 5 - Nature and Contents of Container
  • Change to section 6. 6 - Instructions for use, handling and disposal
Date of revision of text on the SPC:   11/2007
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
2. Qualitative & Quantitative composition - To add full list of excipients.
 
4.4 Special warnings and special precautions for use - To add the following text;
In case of acute symptoms of intolerance, i.e. cramps, abdominal pain, fever, severe headache and rash, the treatment should be discontinued immediately.
Blood tests (differential blood count, liver function parameters like ALT or AST) should be assessed prior to and during treatment, at the discretion of the treating physician.
 
4.5 Interaction with other medicinal products and other forms of interaction - To add the following text;
No specific interaction studies have been performed. Concomitant treatment with mesalazine can increase the risk of blood dyscrasia in patients receiving azathioprine or 6-mercaptopurine.
 
4.8 Undesirable effects - Tp update the side effects table
 
5.1 Pharmacodynamic prop. - To add Pharmacotherapeutic group - Intestinal anti-inflammatory agents.
 
6.4 Special precautions for storage - re-phrased the none storage condition sentence.
 
6.5 Nature & content of container - To add "Not all pack sizes may be marketed".
 
6.6 Special precautions for disposal - To replace the text to "Any unused product or waste material should be disposed of in accordance with local requirements.
 
Updated on 20/05/2005 and displayed until 31/03/2008
Reasons for adding or updating:
  • Change to section 4.8 - Undesirable Effects
  • Change to section 10 (date of (partial) revision of the text
Updated on 07/10/2003 and displayed until 20/05/2005
Reasons for adding or updating:
  • Improved Electronic Presentation
Updated on 30/09/2003 and displayed until 07/10/2003
Reasons for adding or updating:
  • Change to section 1 - trade name
  • Change to section 3 - pharmaceutical form
  • Change to section 4.4 - Special Warnings and Precautions for Use
  • Change to section 4.6 - Pregnancy and Lactation
  • Change to section 4.8 - Undesirable Effects
  • Change to section 6.2 - Incompatibilities
  • Change to section 6. 5 - Nature and Contents of Container
  • Change to section 6. 6 - Instruction for Use/Handling
  • Change to section 9 - Date of Renewal of Authorisation
  • Change to section 10 (date of (partial) revision of the text
Updated on 17/08/2001 and displayed until 30/09/2003
Reasons for adding or updating:
  • Transferred from eMC version 1
Updated on 06/02/2001 and displayed until 17/08/2001
Reasons for adding or updating:
  • No reasons supplied

Active Ingredients/Generics

 
  mesalazine