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 4.3 - 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 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 1 - Name of the medicinal product
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.3 - Contraindications

Date of revision of text on the SPC:01-07-2016

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:



The SPC has been updated as follows:

Section 1             Name amended to “film coated tablets”

Section 4.2          Headings aligned to QRD

Section 4.3          Contraindications updated to include sulphonamide-derived drugs.

                              Contraindication wording revised to: “patients with dynamic left ventricular outflow                               obstruction”.

Section 4.4          Warnings added for patients with Renal disease:

·         Before ACE inhibitor treatment, renal artery stenosis should be excluded in renal transplant patients.

·         Increases in blood urea nitrogen and serum creatinine in patients on quinapril.

                              Warnings added for patients on Thiazide diuretics

                              Warning that lithium should not be given with diuretics.

Section 4.5          Warnings added to include interactions with;

·         Antidiabetic drugs

·         Pressor amines,                              

·         Anion exchange resins.Section 4.8          ADR table updated in line with CSP

 

 

 

 

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 - Fertility, pregnancy and lactation
  • Change to section 5.2 - Pharmacokinetic properties

Date of revision of text on the SPC:01-03-2016

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:



Section 4.3

Update to the pregnancy contraindication

Section 4.4

To include warning in pregnancy section that:

ACE inhibitors should not be initiated during pregnancy. Unless continued ACE inhibitor therapy is considered essential, patients planning pregnancy should be changed to alternative antihypertensive treatments which have an established safety profile for use in pregnancy. When pregnancy is diagnosed, treatment with ACE inhibitors should be stopped immediately, and, if appropriate, alternative therapy should be started (see sections 4.3 and 4.6).

Section 4.6

Extensive update to include information on ACE-inhibitors and their use in pregnancy and lactation.

Section 5.2

Inclusion of information that a breastfed infant would receive about 1.6% of the maternal weight-adjusted dosage of quinapril.

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 - Fertility, pregnancy and lactation
  • 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 6.1 - List of excipients
  • Change to section 6.2 - Incompatibilities
  • Change to section 6.5 - Nature and contents of container
  • Change to section 6.6 - Special precautions for disposal and other handling

Date of revision of text on the SPC:01-12-2015

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

Updates to:

Section 2

QRD update detailing excipients with known effect

Section 3

QRD update to include information tablet shape, colour and scoring

Section 4.2

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

Section 4.3

Grammatical/typographical correction

Section 4.4

To include warnings that:

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

·         Risk of hypokalaemia induced by thiazide diuretics.

·         Thiazide-induced hyperglycaemia may compromise blood sugar control.

Grammatical/typographical correction

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.

·         Thiazide-induced hyperglycaemia may compromise blood sugar control.

·         Thiazide-induced electrolyte disturbances, i.e. hypokalaemia, hypomagnesaemia, increase the risk of digoxin toxicity.

·         Thiazide-induced hyperuricemia may compromise control of gout by allopurinol and probenecid.

Grammatical/typographical corrections

Section 4.6

QRD update to include section headings

Section 4.8

·         Include ADRs;  Acute myopia and acute angle closure glaucoma

·         Include information on Reporting of suspected adverse reactions

·         Grammatical/typographical correction

Section 4.9

Typographical correction

Section 5.1

Update to include ATC code: C09BA06

Section 5.2

Typographical correction

Section 6.1

Typographical correction

Section 6.2

Update in line with QRD

Section 6.5

QRD update; Not all pack sizes may be marketed.

 

Section 6.6

Update in line with QRD

Reasons for adding or updating:

  • Change to section 4.1 - Therapeutic indications
  • 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 5.1 - Pharmacodynamic properties

Date of revision of text on the SPC:01-11-2014

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:



Section 4.1  Therapeutic indications updated with cross reference to “see sections 4.3, 4.4, 4.5 and 5.1”.

Section 4.2  Posology and method of administration updated with cross reference to “see sections 4.3, 4.4, 4.5 and 5.1”.

Section 4.3  Contraindication updated to include concomitant use of Accuretic with aliskiren-containing products in patients with diabetes mellitus or renal impairment.

Section 4.4  Special warnings and precautions updated to include warning that Dual blockade of RAAS through the combined use of ACE-inhibitors, angiotensin II receptor blockers or aliskiren is not recommended

Section 4.5 Interaction with other medicinal products and other forms of interaction updated to include information that 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.

Section 5.1  Pharmacodynamic properties updated to include clinical trial data showing no significant beneficial effect of the combination of an ACE-inhibitor with an angiotensin II receptor blocker.

Reasons for adding or updating:

  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction

Date of revision of text on the SPC:01-04-2013

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

Section 4.5 (To include wording on the on inclusion of an interaction with NSAIDs)

Reasons for adding or updating:

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.2 - Posology and method of administration
  • 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 10 date of revision of the text

Date of revision of text on the SPC:01-11-2011

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

Updates to sections  2 (Qualitative and Quantitative composition); 4.4 ( Special warnings and special precautions) ; 4.5 (Interactions with other medicaments)  4.6  ( Pregnancy and lactation); and 10 (Date of partial revision of the text )  

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
  • Change to section 4.6 - Pregnancy and Lactation
  • Change to section 4.8 - Undesirable Effects

Date of revision of text on the SPC:01-07-2010

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

Updates to sections 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) and 4.8 (Undesirable effects)

Reasons for adding or updating:

  • Change to section 4.2 - Posology and Method of Administration
  • Change to section 4.5 - Interactions with other Medicaments and other forms of Interaction
  • Change to section 4.7 - Effects on Ability to Drive and Use Machines
  • Change to section 4.8 - Undesirable Effects
  • Change to section 5.2 - Pharmacokinetic 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:

  • Change to section 4.4 - Special Warnings and Precautions for Use
  • Change to section 4.8 - Undesirable Effects

Reasons for adding or updating:

  • Change to section 4.4 - Special Warnings and Precautions for Use
  • Change to section 4.8 - Undesirable Effects

Reasons for adding or updating:

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