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Discovery Pharmaceuticals Ltd
The Old Vicarage, Market Place, Castle Donington, Derbyshire, DE74 2JB
Telephone: +44 (0) 845 2416616
Fax: +44 (0) 845 2419919
Medical Information Direct Line: 0
Medical Information e-mail: medinfo@discoverypharma.co.uk

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: 29/02/2012
SPC Amlostin 10mg

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 29/02/2012 and displayed until Current
Reasons for adding or updating:
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 3 - Pharmaceutical form
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.3 - Contraindications
  • 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 4.6 - Pregnancy and Lactation
  • Change to section 4.7 - Effects on Ability to Drive and Use Machines
  • Change to section 4.8 - Undesirable Effects
  • Change to section 4.9 - Overdose
  • 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:   01-Aug-2010
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company


To update sections 2 (Qualitative), 4.2 (Posology), 4.3 (Contraindications), 4.4

(Special warnings and precautions for use), 4.5 (Interaction with other medicinal

products and other forms of interaction), 4.6 (Pregnancy and lactation), 4.7

(Effects on ability to drive and use machines), 4.8 (Undesirable effects), 4.9

(Overdose), 5.1 (Pharmacodynamic properties) and 5.2 (Pharmacokinetic

properties) of the SPC and consequentially the leaflet as requested in the Final

PSUR Assessment Report of the p-RMS DK in May 2009
Updated on 19/02/2010 and displayed until 29/02/2012
Reasons for adding or updating:
  • Change to section 1 -Name of the Medicinal product
  • Change to section 6. 3 - Shelf Life
  • Change to section 7 - Marketing Authorisation Holder
  • Change to MA holder contact details
Date of revision of text on the SPC:   11-Jun-2008
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company


·          Change in name of product in the UK - Amlodipine to Amlostin 09/06/04

·          Change in name of MAH in the UK (SPUK to Genus Pharmaceuticals Ltd) 12/04/05

·          Shelf life extension - 24 mths to 36 mths  26/06/06

·          Change to address for UK MAH Genus Pharmaceuticals 13/06/2008

 

 

 

 

 
Updated on 22/09/2004 and displayed until 19/02/2010
Reasons for adding or updating:
  • New SPC for eMC ie an SPC for an existing product, but one that is new for the eMC

Active Ingredients/Generics

 
  amlodipine maleate