Last Updated on eMC 02-01-2018 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 4.8 - Undesirable effects

Date of revision of text on the SPC:01-12-2017

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:



The SPC is updated in section 4.8

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 4.3 - Contraindications
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.6 - Fertility, pregnancy and lactation
  • Change to section 4.8 - Undesirable effects - how to report a side effect
  • Change to section 5.2 - Pharmacokinetic properties
  • Change to section 5.3 - Preclinical safety data
  • Change to section 6.6 - Special precautions for disposal and other handling

Date of revision of text on the SPC:01-05-2017

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:



The SPC is updated in section 2, 4.2, 4.3, 4.4, 4.5, 4.6, 4.8, 5.2, 5.3, 6.6 and QRD changes

Reasons for adding or updating:

  • Change to section 4.8 - Undesirable effects - how to report a side effect

Date of revision of text on the SPC:01-03-2017

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:



Approved changes are in line with PRAC recommendation

The following changes to the labelling have been approved. Please refer to attached copies of labelling documentation for full details.

The SPC is updated in section 4.8

The PIL has been updated in section 4. See PIL tick list for sections updated.

The PI is not affected

The packaging (label/carton) are affected

Implementation Responsibilities – Brand Marketing

SPC     UK Brand Marketing

Please implement in line with REG08-WI-GBR04 SPC release and withdrawal

Not affected

 

PI     UK Brand Marketing

Please implement in line with REG08-WI-GBR05 The Use of prescribing information

Not affected

Reasons for adding or updating:

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 5.1 - Pharmacodynamic properties

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

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:



The SPC is updated in section 4.4 and 5.1

Reasons for adding or updating:

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 5.1 - Pharmacodynamic properties

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

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:



The SPC is updated in section 4.4 and 5.1

Reasons for adding or updating:

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 5.1 - Pharmacodynamic properties

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

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:



The SPC is updated in section 4.4 and 5.1

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:01-01-2016

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 and date of grant of renewal.

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:01-01-2016

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

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 4.8 - Undesirable Effects

Date of revision of text on the SPC:01-06-2012

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

4.4 – addition of hypomagnesaemia text, increased risk of hip, wrist and spine fracture with use of PPIs

4.8 – addition of adverse effects: fracture of the hip, wrist or spine; hypomagnesaemia



Reasons for adding or updating:

  • Change to section 7 - Marketing Authorisation Holder
  • Change to section 8 - MARKETING AUTHORISATION NUMBER(S)
  • Change to section 9 - Date of first Authorisation/renewal of the Authorisation
  • Change to section 10 date of revision of the text

Date of revision of text on the SPC:17-06-2011

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:



Section 7: MA Holder name and address (Wyeth Pharmaceuticals, Taplow to Pfizer Limited, Sandwich)

Section 8: MA Numbers (changed to reflect ownership by Pfizer under “PL 00057”)

Section 9: Date of First Authoisation

Section 10: Date of revision of the text

Reasons for adding or updating:

  • Change to section 4.2 - Posology and method of administration

Date of revision of text on the SPC:17-02-2011

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:



Section 4.2 – the underlined text has been added:

The use of Zoton FasTab is not recommended in children as clinical data are limited (see also section 5.2). Treatment of small children below one year of age should be avoided as available data have not shown beneficial effects in the treatment of gastro-oesophageal reflux disease.

Reasons for adding or updating:

  • Change to section 3 - Pharmaceutical form

Date of revision of text on the SPC:01-08-2007

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

Section 3
Product description amended to include debossed number on tablets.

Reasons for adding or updating:

  • Change due to harmonisation of SPC

Date of revision of text on the SPC:01-05-2007

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

SPC update in line with Article 30 EC Decision on lansoprazole

Reasons for adding or updating:

  • Correction of spelling/typing errors

Reasons for adding or updating:

  • Correction of spelling/typing errors

Reasons for adding or updating:

  • Change to section 4.1 - Therapeutic Indications
  • Change to section 4.2 - Posology and Method of Administration

Reasons for adding or updating:

  • Change to section 7 - Marketing Authorisation Holder
  • Change to section 8 - MA number
  • Change to section 9 - Date of Renewal of Authorisation

Reasons for adding or updating:

  • Change to section 1 - trade name
  • Change to section 2 - qualitative and quantitative composition
  • Change to section 3 - pharmaceutical form
  • Change to section 4.8 - Undesirable Effects

Reasons for adding or updating:

  • Change to section 6. 3 - Shelf Life

Reasons for adding or updating:

  • New SPC for new product