Last Updated on eMC 06-07-2017 View medicine  | Actavis UK Ltd 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
  • Change to section 10 - Date of revision of the text

Date of revision of text on the SPC:31-05-2017

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:



4.8

Gastrointestinal

Disorders

 

Nausea, diarrhoea,

stomach ache,

constipation,

vomiting,

flatulence, dry

mouth or throat

 

, fundic gland polyps (benign)


 

Lansoprazole 15mg & 30mg Gastro-Resistant Capsules – PL 30306/0148 & 0149 - IS/H/0195/001-002/IAin/020

 

Variation approval date31/05/2017

(Variation approval received date – 01/06/2017)

 

Single Variation

Variation Type: IAin C.I.z

 

Variation Description: Update to the product information in line with Pharmacovigilance Risk Assessment Committee (PRAC) recommendations (EMA/PRAC/740369/2016, EPITT No 18725) for proton pump inhibitors (PPIs): dexlansoprazole; esomeprazole; lansoprazole; omeprazole;pantoprazole; rabeprazole (Gastric polyps), published on 03-01-2017.

 

SmPC sections updated 4.8 and 10

PIL  sections updated – 4 and 6

Reasons for adding or updating:

  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.6 - Fertility, pregnancy and lactation
  • 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:25-11-2016

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:



Lansoprazole 15, 30 mg Gastro-Resistant Capsules, PL 30306/0148, 0149

IS/H/0195/001-002/IB/015

 

Variation approval date – 29.05.2015

RMS approval received – 01.06.2015

MHRA approval received – 14.12.2016

 

Single variation

Variation type – IB, C.I.z

 

Variation description – Update to the product information in  line with the latest QRD-template (version 3.0, 04/2013) and recommendations from annotated QRD-template (version 9, 03/2013).

 

SmPC sections updated – 4.2, 4.4, 4.6, 4.8 and 10

Reasons for adding or updating:

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 10 - Date of revision of the text

Date of revision of text on the SPC:25-11-2016

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:



Lansoprazole 15mg & 30mg Gastro-Resistant Capsules - PL 30306/0148 & 0149 (IS/H/0195/001-002/IAin/019)

 

Variation approval date – 25/11/2016

 

Single variation

Variation Type: IAin C.I.z

 

Variation Description: Update to product information in line with Pharmacovigilance Risk Assessment Committee (PRAC) recommendations (EMA/PRAC/452657/2016, EPITT No 18614) for proton pump inhibitors (PPIs): dexlansoprazole; esomeprazole; lansoprazole; omeprazole; pantoprazole; rabeprazole (Elevated levels of Chromogranin A), published on 02-08-2016.

 

SmPC sections updated – 4.4, 5.1 & 10

PIL  sections updated – 2 & 6

Reasons for adding or updating:

  • Change to section 4.4 - Special warnings and precautions for use
  • 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:27-11-2015

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

Section 4.4 has been updated to include the warning regarding Subacute cutaneous lupus erythematosus (SCLE).
In Section 4.8 (undesirable effects), Subacute cutaneous lupus erythematosus (SCLE) has been added.

Reasons for adding or updating:

  • Product/presentation re-marketed

Date of revision of text on the SPC:26-06-2013

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

Product is now on the market

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 4.6 - Fertility, 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 5.3 - Preclinical safety data
  • Change to section 10 - Date of revision of the text

Date of revision of text on the SPC:09-05-2013

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

To update clinical sections of the SPC and PIL for Lansoprazole 15,30mg Gastro-resistant Capsules, in line with currently approved SPC Lansoprazole 15mg Gastro-resistant Capsules, PL30306/0148.

Reasons for adding or updating:

  • Change to section 4.8 - Undesirable Effects

Date of revision of text on the SPC:31-07-2012

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

Text missing in section 4.8

Reasons for adding or updating:

  • Change to section 4.4 - Special warnings and precautions for Use
  • 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:31-07-2012

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

To update section 4.4 (Special Warnings) and 4.8 (Undesirable Effects) of the SPC in line with PhVWP (CMDh/PhVWP/047/2012) and (CMDh/PhVWP/048/2012) to include information concerning proton pump inhibitors the risk of fractures to the hip, wrist and spine as well as severe hypomagnesaemia. Consequently the leaflet has been updated.

SPC sections affected – 4.4, 4.8 and 10

 

Reasons for adding or updating:

  • New SPC for new product

Date of revision of text on the SPC:01-01-0001

Legal Category:POM

Black Triangle (CHM): NO