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Submissions and TGA response: cimetidine, famotidine, nizatidine and ranitidine: corrected advisory statement for medicines

23 November 2015

The TGA would like to thank the respondents who have submitted written comments or made submissions in response to the Consultation: cimetidine, famotidine, nizatidine and ranitidine: corrected advisory statement for medicines.

Submissions received

Three submissions were received.

How to access a pdf document

Two of the respondents supported the warning statements as proposed. One of these respondents also proposed that these changes should be included in the Product Information and Consumer Medicines Information (CMI) for these medicines, and that all medicine boxes should contain a CMI leaflet.

The other respondent supported the statement, but proposed that the instruction to consult a doctor should be broadened to also include pharmacists or health professionals more generally; on the basis that pharmacists are in a position to determine whether a patient should try an alternative OTC treatment or whether a referral to a doctor is required.

TGA response

The TGA considers that it is not appropriate to broaden the statement as proposed by the respondent for the following reasons:

  • The Pharmaceutical Society of Australia's (PSA) guidelines on gastro-oesophageal reflux disease (GORD) counselling for pharmacists state that patients should be referred to a doctor when symptoms are not adequately controlled after a 2-week trial of H2-antagonist or PPIs.
  • For OTC use, the SUSMP allows only for pack sizes that contain no more than14 days' supply of these medicines. It would be contrary to the intent of this pack size limit if patients were to use consecutive packs of OTC products, without a doctor's advice.

The TGA agrees that the corrected statement should be included in the Product Information and Consumer Medicines Information (CMI) for these medicines, when these documents are required; and that CMI documents should be available to consumers. However, it is not a TGA requirement to include a CMI in all medicine boxes.

Outcome

The advisory statement 'If symptoms persist or recur within two weeks, consult a doctor' is proposed for inclusion on the labelling of all OTC medicines containing cimetidine, famotidine, nizatidine or ranitidine.

The transition period for this new requirement will be 18 months from the date of publication on the Federal Register of Legislative Instruments (FRLI) of the next update to the Medicines Advisory Statements Specification. For those sponsors who are affected, the TGA will allow sponsors to submit a change application (C1) using the change code 'LLO' to include the new proposed RASML warning statements provided that there are no other changes made in that application with the exception of other C1 changes.

The RASML permits variation of the wording of the warning statements specified in the document provided that the intent is not changed. In the case of affected existing medicines that include the current RASML statement 'If symptoms persist or recur within two weeks of completing the course, consult a doctor', the current statement is considered to have the same intent as the corrected statement. Sponsors will be expected to change the statement as part of the next label update; but the amendment does not introduce any requirement to amend the labels of any currently registered medicine.

Final proposal

Corrected advisory statement for cimetidine, famotidine, nizatidine and ranitidine

As originally proposed, the following advisory statements will be included in the next update to the Medicines Advisory Statements Specification (proposed for publication on the FRLI on 1 January 2016, with an 18-month transition period).

Column 1
Substances
Column 2
Conditions
Column 3
Required statement
Cimetidine In medicines for oral use
  • Use only under medical supervision if you are taking other medicines.#
  • 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, consult a doctor.

# Existing RASML statement

Column 1
Substances
Column 2
Conditions
Column 3
Required statement
Famotidine 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, consult a doctor.

# Existing RASML statement

Column 1
Substances
Column 2
Conditions
Column 3
Required statement
Nizatidine 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, consult a doctor.

# Existing RASML statement

Column 1
Substances
Column 2
Conditions
Column 3
Required statement
Ranitidine 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, consult a doctor.

# Existing RASML statement