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Submissions and TGA response: Esomeprazole: proposed advisory statement for medicines

1 December 2014

The TGA would like to thank the respondents who have submitted written comments or made submissions in response to the consultation: Esomeprazole: proposed advisory statements for medicines.

Submissions received

Three submissions were received. The following submissions provided consent for publication on the TGA website:

How to access a pdf document

The respondents supported the warning statements as proposed.

TGA response (Final proposal)

Advisory statements for esomeprazole

As originally proposed, the following advisory statements will be included in the Required Advisory Statements for Medicine Labels (RASML) document when it is next updated.

Column 1
Substance(s)
Column 2
Conditions
Column 3
Required statement(s)
Esomeprazole In medicines for oral use
  • CAUTION - This preparation is for the relief of minor and temporary ailments and should be used strictly as directed.
  • If symptoms persist or recur within two weeks of completing the course, consult a doctor.
  • Ask your doctor or pharmacist before use if you are taking other medicines regularly.

Amendment to class entry for advisory statements for proton pump inhibitors

As originally proposed, the existing RASML class entry for proton pump inhibitors will be amended to include esomeprazole in the list of substances in Column 1 in the Table, as follows.

Column 1
Substance(s)
Column 2
Conditions
Column 3
Required statement(s)

Proton pump inhibitors including:

  • Esomeprazole
  • Lansoprazole
  • Omeprazole
  • Pantoprazole
  • Rabeprazole
In medicines for oral use
  • CAUTION - This preparation is for the relief of minor and temporary ailments and should be used strictly as directed.
  • If symptoms persist or recur within two weeks of completing the course, consult a doctor.
  • Ask your doctor or pharmacist before use if you are taking other medicines regularly.