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

Summary of Product Characteristics last updated on the eMC: 23/03/2011
SPC Amilamont 5mg/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 23/03/2011 and displayed until Current
Reasons for adding or updating:
  • Change to section 4.8 - Undesirable Effects
  • Change to section 6.1 - List of Excipients
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

Section 4.8 (undesirable effects) in the Cardiovascular section, orthostatic hypotension has replaced orthostatic hypertension.

Section 6.1 (list of excipients). Citric Acid Monohydrate, Methyl Hydroxybenzoate, Propyl Hydroxybenzoate, Propylene Glycol, Vanillin and Purified Water now use Ph. Eur as the reference standard rather than the BP.
Updated on 11/01/2010 and displayed until 23/03/2011
Reasons for adding or updating:
  • Change to section 4.8 - Undesirable Effects
Date of revision of text on the SPC:   07-Aug-2009
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company



In section 4.8 (undesirable effects) Additions: Serum uric acid levels may rise during treatment with Amiloride and acute attacks of gout may be precipitated.

Updated on 21/09/2009 and displayed until 11/01/2010
Reasons for adding or updating:
  • 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:   07-Aug-2009
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company

Section 4.8: Additions: Serum uric acid levels may rise during treatment with Amiloride and acute attacks of gout may be precipitated.  
Updated on 02/08/2007 and displayed until 21/09/2009
Reasons for adding or updating:
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   07/2007
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company

Section 4.5: CHlorthiazide amended to chlorpropramide. Additional paragraph re: diuretics
Updated on 25/09/2002 and displayed until 02/08/2007
Reasons for adding or updating:
  • New SPC for new product

Active Ingredients/Generics

 
   amiloride hydrochloride