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Rosemont Pharmaceuticals Limited
Rosemont House, Yorkdale Industrial Park, Braithwaite Street, Leeds, Yorkshire, LS11 9XE
Telephone: +44 (0)113 244 1400
Fax: +44 (0)113 246 0738
WWW: http://www.rosemontpharma.com
Customer Care direct line: +44 (0)800 919 312
Out of Hours Telephone: +44 (0)7836 557 879
Out of Hours contact: pharmacovigilance@rosemontpharma.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: 12/11/2009
SPC Cimetidine 200mg/5ml Oral Solution

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 12/11/2009 and displayed until Current
Reasons for adding or updating:
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.4 - Special warnings and precautions for Use
  • Change to section 5.1 - Pharmacodynamic Properties
  • Change to section 5.2 - Pharmacokinetic Properties
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   17-Sep-2009
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company


4.2: Added: Avoid in general anaesthesia and management of labour

4.4: Added: Exclude malignancy by endoscopy and biopsy before use for gastric ulceration

5.1: Re-written with more detail

5.2: More detail
Updated on 31/10/2007 and displayed until 12/11/2009
Reasons for adding or updating:
  • Change to section 4.4 - Special warnings and precautions for Use
  • Change to section 4.8 - Undesirable Effects
  • Change to section 10 date of revision of the text
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
Section 4.4: Updated Excipient warnings (Propylene glycol, liquid maltitol, hydroxybenzoates)
Section 4.8: Added hypersensitivity vasculitis and hepatitis.
Section 10: Updated to Novemebr 2006
Updated on 28/07/2005 and displayed until 31/10/2007
Reasons for adding or updating:
  • Change to section 6. 3 - Shelf Life
Updated on 26/07/2005 and displayed until 28/07/2005
Reasons for adding or updating:
  • Change to section 6. 3 - Shelf Life
  • Change to section 10 (date of (partial) revision of the text
  • Pending awaiting re-submission
Updated on 05/03/2003 and displayed until 26/07/2005
Reasons for adding or updating:
  • Improved Electronic Presentation
Updated on 25/09/2002 and displayed until 05/03/2003
Reasons for adding or updating:
  • New SPC for new product

Active Ingredients/Generics

 
  cimetidine