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Sandoz Limited

200 Frimley Business Park, Frimley, Camberley, Surrey, GU16 7SR, UK
Telephone: +44 (0) 1276 698020
Fax: +44 (0) 1276 698324
WWW: http://www.sandoz.com
Medical Information e-mail: sandoz@professionalinformation.co.uk
Medical Information Fax: +44 (0) 1276 698468

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: 03/05/2011
SPC Ipocol 400mg MR 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 03/05/2011 and displayed until Current
Reasons for adding or updating:
  • Change to section 4.2 - Posology and method of administration
  • 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 6. 6 - Instructions for use, handling and disposal
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   01-Mar-2011
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company


4.2       Posology and method of administration

 

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 at 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.

4.5       Interactions with other medical products and other forms of interaction 
4.6       Fertility, pregnancy and lactation

6.6       Special precautions for disposal

10.    DATE OF REVISION OF THE TEX
Updated on 07/10/2010 and displayed until 03/05/2011
Reasons for adding or updating:
  • Change to section 4.4 - Special warnings and precautions for Use
  • Change to section 7 - Marketing Authorisation Holder
Date of revision of text on the SPC:   19-Jul-2010
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company

  • In section 4.4, exacerbation of symptoms of colitis and bullous skin reactions including erythema added
  • In section 7, MA holder address changed
Updated on 21/12/2009 and displayed until 07/10/2010
Reasons for adding or updating:
  • Change to section 1 -Name of the Medicinal product
Date of revision of text on the SPC:   01-Oct-2009
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
In section 1, Mezzatard has been removed as an alternative name
Updated on 16/04/2009 and displayed until 21/12/2009
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:   POM
Black Triangle (CHM):   NO

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

Active Ingredients/Generics

 
  mesalazine