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Pfizer Limited
Ramsgate Road, Sandwich, Kent, CT13 9NJ
Telephone: +44 (0)1304 616 161
Fax: +44 (0)1304 656 221

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: 30/09/2011
SPC Accupro Tablets 5mg, 10mg, 20mg & 40mg

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 30/09/2011 and displayed until Current
Reasons for adding or updating:
  • Change to section 4.2 - Posology and method of administration
  • Change to section 5.1 - Pharmacodynamic Properties
  • Change to section 5.2 - Pharmacokinetic Properties
Date of revision of text on the SPC:   01-Aug-2011
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company


Section 4.2 – Updated to include recommended wording for children

Section 5.1 and 5.2 – Updated to provide information on paediatric studies
Updated on 07/07/2009 and displayed until 30/09/2011
Reasons for adding or updating:
  • Change to section 4.3 - Contraindications
  • Change to section 4.4 - Special warnings and precautions for Use
  • Change to section 4.6 - Pregnancy and Lactation
  • Change to section 5.2 - Pharmacokinetic Properties
Date of revision of text on the SPC:   01-Jun-2009
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
 Section 4.3
  • Amendment of contraindication in pregnancy to state that Accupro is contraindicated during the second and third trimesters of pregnancy
  • Removal of contraindication in nursing mothers

Section 4.4

  • Addition of precautions for use in pregnancy

Section 4.6

  • Addition of precautions for use in pregnancy and lactation

Section 5.2

  • Addition of pharmacokinetic data on the presence of quinapril in breast milk

 
Updated on 30/03/2007 and displayed until 07/07/2009
Reasons for adding or updating:
  • Change to section 3 - Pharmaceutical form
  • Change to section 4.2 - Posology and method of administration
Date of revision of text on the SPC:   03/2007
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
 

3 – Updated to include the full product description

4.2 – updated change use of BANs (british approved names) to INNs (international non-proprietary names)
Updated on 21/02/2007 and displayed until 30/03/2007
Reasons for adding or updating:
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.3 - Contraindications
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
Date of revision of text on the SPC:   01/2007
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company

4.2 – administrative changes to update cross referencing

4.3 – administrative changes to update cross referencing

4.5 – additional descriptive text regarding existing interactions
Updated on 21/02/2007 and displayed until 21/02/2007
Reasons for adding or updating:
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.3 - Contraindications
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
Date of revision of text on the SPC:   01/2007
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company

4.2 – administrative changes to update cross referencing

4.3 – administrative changes to update cross referencing

4.5 – additional descriptive text regarding existing interactions
Updated on 10/07/2006 and displayed until 21/02/2007
Reasons for adding or updating:
  • Change to section 3 - pharmaceutical form
Date of revision of text on the SPC:   06/2006
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company

Section 3 of SmPC was updated to reflect change in appearance of the finished tablets.
Updated on 07/07/2006 and displayed until 10/07/2006
Reasons for adding or updating:
  • Change to section 3 - pharmaceutical form
Date of revision of text on the SPC:   12/2005
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
CHANGE TO SECTION 3: from 'brown, elliptical film coated tablet imprinted with the dosage strength' to 'reddish-brown oval, biconvex film-coated tablet with debossing '40' on one side and 'PD 535'  on the other side'
Updated on 06/04/2006 and displayed until 07/07/2006
Reasons for adding or updating:
  • Change to section 4.2 - Posology and Method of Administration
  • Change to section 5.1 - Pharmacodynamic Properties
  • Change to section 10 (date of (partial) revision of the text
Updated on 06/01/2006 and displayed until 06/04/2006
Reasons for adding or updating:
  • Improved Electronic Presentation
Updated on 28/09/2005 and displayed until 06/01/2006
Reasons for adding or updating:
  • Improved Electronic Presentation
Updated on 28/09/2005 and displayed until 28/09/2005
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

 
  quinapril hydrochloride