Last Updated on eMC 05-04-2017 View medicine  | GlaxoSmithKline UK 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 4.2 - Posology and method of administration
  • Change to section 10 - Date of revision of the text

Date of revision of text on the SPC:22-03-2017

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

Section 4.2 of the SmPC has been amended to reflect the correct dosing recommendations for oral amoxicillin in adults and children ≥ 40 kg undergoing haemodialysis

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 4.7 - Effects on ability to drive and use machines
  • 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
  • Change to section 5.3 - Preclinical safety data
  • Change to section 9 - Date of first authorisation/renewal of the authorisation
  • Change to section 10 - Date of revision of the text
  • Change to section 11 - Dosimetry
  • Change to section 4.6 - Fertility, pregnancy and lactation

Date of revision of text on the SPC:29-02-2016

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:



Section 4.1 – harmonisation of indications across the EU

Section 4.2 – harmonisation of the recommendations on how to use Amoxil.

Section 4.3 – editorial changes

Section 4.4 – harmonisation of warnings across the EU

Section 4.5, 4.6, 4.7, 4.8, 4.9, 5.1, 5.2, 5.3 – harmonisation of information across the EU

Section 4.8 - addition of reporting of suspected adverse reactions

Section 9 – editorial changes

Section 10 - date

Section 11 – legal status removed

Reasons for adding or updating:

  • Change to section 4.1 - Therapeutic indications
  • Change to section 10 date of revision of the text

Date of revision of text on the SPC:04-01-2012

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:



Section

Summary of change

4.1

Addition of new paragraph:- Consideration should be given to official local guidance (e.g. national requirements) on the appropriate use of antibacterial agents. Susceptibility of the causative organism to the treatment should be tested (if possible), although the therapy may be initiated before the results are available.

10.

Updated with new date of revision of text

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 5.2 - Pharmacokinetic Properties
  • Change to section 8 - MARKETING AUTHORISATION NUMBER(S)
  • Change to section 10 date of revision of the text

Date of revision of text on the SPC:17-11-2010

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

Sections changed:

4.2 Change from paediatric dosing by age to by weight instead
4.4 Addition of preaution for prenatal and neonatal children
5.2 Addition of information relating to dosing of pre-term infants
8 Correction to PL stem number
10 Date of revision of the text

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:01-03-2010

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

Section 4.4 - Addition of text with regards to prolongation of prothrombin time

Section 4.5 - Deletion and addition of text with regards to prolongation of prothrombin time

Section 4.8 - Changes made under Blood and lymphatic system disorders

Section 10 - Date of approval added

Reasons for adding or updating:

  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 4.2 - Posology and method of administration
  • 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:26-09-2008

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

Section 4.2 - lignocaine changed to lidocaine

Section 4.5 - Header changed + new paragraph on probenecid

Section 4.8 - Addition of infections and infestations + hairy black tongue

Section 10 - Date changed

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 4.9 - Overdose

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 4.9 - Overdose

Reasons for adding or updating:

  • Pending awaiting re-submission
  • Change to section 4.4 - Special Warnings and Precautions for Use
  • Change to section 4.8 - Undesirable Effects
  • Change to section 4.9 - Overdose

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