Last Updated on eMC 06-10-2017 View medicine  | Pfizer Limited Contact details

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.

Reasons for adding or updating:

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects

Date of revision of text on the SPC:01-10-2017

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

Section 4.4 & 4.8 have been updated to add warning about hyponatraemia and Syndrome of Inappropriate Anti-diuretic Hormone (SIADH).

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 4.5 - Interaction with other medicinal products and other forms of interaction

Date of revision of text on the SPC:01-10-2017

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:



Section 4.3 to add concomitant use with sacubitrol/valsartan as a contraindication

Section 4.4 to add warnings regarding concomitant use with sacubitrol/valsartan and NEP inhibitors

Section 4.5 to describe interactions with sacubitrol/valsartan and NEP inhibitors

Reasons for adding or updating:

  • Change to section 3 - Pharmaceutical form

Date of revision of text on the SPC:01-06-2016

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:



The SmPC has been updated as follows:

·         Section 3 change in description to state the tablet is debossed on both sides

Reasons for adding or updating:

  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.3 - Contraindications
  • Change to section 4.4 - 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 - Fertility, pregnancy and lactation
  • Change to section 4.8 - Undesirable effects
  • Change to section 4.8 - Undesirable effects - how to report a side effect
  • Change to section 4.9 - Overdose
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 5.2 - Pharmacokinetic properties

Date of revision of text on the SPC:01-01-2016

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:



Section 4.2

QRD update to include section headings and statement  that tablets should not be chewed, crushed or divided

Section 4.3

Addition of the contraindications:

·         Accupro should not be used in patients with dynamic left ventricular outflow obstruction.

·         The concomitant use of Accupro with aliskiren-containing products is contraindicated in patients with diabetes mellitus or renal impairment (GFR < 60 ml/min/1.73 m2) (see sections 4.5 and 5.1).

 

QRD update, Grammatical/typographical corrections

Section 4.4

To include warnings of:

·         Sensitivity reactions

·         Hyperkalaemia

·         Impaired hepatic function, specifically - ACE inhibitors have been associated with a syndrome beginning as a cholestatic jaundice and progressing to a fulminant hepatic necrosis (in some cases fatal).

·         Impaired Renal Function

·         Concomitant use of ACE-inhibitors, angiotensin II receptor blockers or aliskiren increases the risk of hypotension, hyperkalaemia and decreased renal function (including acute renal failure). Dual blockade of RAAS through the combined use of ACE-inhibitors, angiotensin II receptor blockers or aliskiren is therefore not recommended.

·         Increased risk of angioedema while receiving an ACE inhibitor therapy.

·         Patients taking concomitant mTOR inhibitor (e.g. temsirolimus) or concomitant DPP-IV inhibitor (e.g. vildagliptin) therapy may be at increased risk for angioedema.

·         Lactose excipient.

 

Grammatical/typographical corrections

Section 4.5

To include warnings that:

·         Co-administration of an ACE inhibitor with sulfamethoxazole/trimethoprim in elderly patients with compromised renal function has been associated with severe hyperkalaemia.

·         Patients taking concomitant mTOR inhibitor (e.g. temsirolimus) or concomitant DPP-IV inhibitor (e.g. vildagliptin) therapy may be at increased risk for angioedema.

·         Dual blockade of the RAAS through the combined use of ACE-inhibitors, angiotensin II receptor blockers or aliskiren is associated with a higher frequency of adverse events.

·         Do not co-administer aliskiren with quinapril in patients with diabetes or in patients with renal impairment.

 

Grammatical/typographical corrections

Section 4.6

QRD update to include section headings

Section 4.8

·         Update to ADR table

·         Include information on Reporting of suspected adverse reactions

·         Grammatical/typographical correction

Section 4.9

Update to include oral LD50 of quinapril in rodents.

Typographical correction

Section 5.1

Update to include data from two large randomised, controlled trials (ONTARGET and VA NEPHRON-D)

Section 5.2

Typographical correction

Reasons for adding or updating:

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects
  • Change from joint to individual SPC

Date of revision of text on the SPC:01-01-2016

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:



The SPC has been updated as Follow:

The SPC has been updated in section 4.4 & 4.8 to update Proton Pump inhibitor information.

Reasons for adding or updating:

  • 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 4.8 - Undesirable Effects
  • Change to section 10 date of revision of the text

Date of revision of text on the SPC:01-08-2012

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:



Section 4.5 (Interactions with other medicinal products and other forms of interaction)
Section 4.4 (Special warnings and precautions for use);
Section 4.5 (Interactions with other medicinal products and other forms of interaction);
Section 4.8 (Undesirable effects);
Section 10 (date of partial revision of the text

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:01-08-2011

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

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:01-06-2009

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

 

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:01-03-2007

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)

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:01-01-2007

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

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:01-01-2007

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

Reasons for adding or updating:

  • Change to section 3 - pharmaceutical form

Date of revision of text on the SPC:01-06-2006

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.

Reasons for adding or updating:

  • Change to section 3 - pharmaceutical form

Date of revision of text on the SPC:01-12-2005

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'

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

Reasons for adding or updating:

  • Improved Electronic Presentation

Reasons for adding or updating:

  • Improved Electronic Presentation

Reasons for adding or updating:

  • New SPC for eMC ie an SPC for an existing product, but one that is new for the eMC