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Chugai Pharma UK Limited
Mulliner House, Flanders Road, Turnham Green, London, W4 1NN
Telephone: +44 (0)208 987 5600
Fax: +44 (0)208 987 5660

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: 15/11/2010
SPC Antepsin 1g/5ml Oral Suspension

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 15/11/2010 and displayed until Current
Reasons for adding or updating:
  • Change due to harmonisation of SPC
Date of revision of text on the SPC:   05-Nov-2007
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company

  • Harmonisation of description of list of excipients (Sodium dihydrogen phosphate now reads Sodium dihydrogen phosphate dihydrate Ph. Eur).
Updated on 22/01/2008 and displayed until 15/11/2010
Reasons for adding or updating:
  • Change to section 4.2 - Posology and method of administration
  • Change to section 6.1 - List of Excipients
  • Change to section 10 date of revision of the text
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
Minor amendments have been made to harmonise UK and Irish SmPC's:
 
Section 4.2 Removal of statement on dispersing tablet in water
 
Section 6.1 'Sodium saccharin' changed to 'Saccharin sodium', spelling of 'xanthan gum' and 'purified water' added
Updated on 01/12/2006 and displayed until 22/01/2008
Reasons for adding or updating:
  • Change to section 1 -Name of the Medicinal product
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 3 - Pharmaceutical form
  • 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 4.7 - Effects on Ability to Drive and Use Machines
  • Change to section 4.8 - Undesirable Effects
  • Change to section 6.1 - List of Excipients
Date of revision of text on the SPC:   11/2006
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
 
Sections 1 to 3: Updated in line with EU SmPC Guideline
 
Section 4.4: Allergy warning added in line with EU excipients guideline (relevant to excipients E217 and E219)

Section 4.5: Theophylline, thyroxine and quinidine added. Concomitant administration of Antepsin may reduce the bioavailability of these drugs.

Section 4.7: Driving warning updated as drowsiness and dizziness are listed as undesirable effects

Section 4.8: 'Shortness of breath' added in line with patient information leaflet

Section 6.1: Updated to refer to excipients E217 and E219 by full names
Updated on 27/10/2005 and displayed until 01/12/2006
Reasons for adding or updating:
  • Change to section 4.6 - Pregnancy and Lactation
  • Change to section 4.9 - Overdose
  • Change to section 5.1 - Pharmacodynamic Properties
  • Change to section 9 - Date of Renewal of Authorisation
  • Change to section 10 (date of (partial) revision of the text
Updated on 03/06/2003 and displayed until 27/10/2005
Reasons for adding or updating:
  • Change to section 6. 5 - Nature and Contents of Container
  • Change to section 10 (date of (partial) revision of the text
Updated on 28/08/2001 and displayed until 03/06/2003
Reasons for adding or updating:
  • No reasons supplied
Updated on 02/11/2000 and displayed until 28/08/2001
Reasons for adding or updating:
  • No reasons supplied

Active Ingredients/Generics

 
  sucralfate