Published: 2 August 2017

Consultations

Changes to the Label Statements Database for sedating antihistamines available without prescription

Closing date: 29 September 2017

This consultation is intended to:

• Propose changes to the labelling requirements for sedating antihistamines that are available without prescription
• Provide an opportunity for consultation on these changes
• Provide a contact point for queries or feedback on the proposed changes

About the consultation

Medsafe is seeking comments and input from interested parties on the proposed changes to the labelling requirements for sedating antihistamines that are available without a prescription.

Table 1 summarises the proposed warning statement changes regarding use of sedating antihistamines that are available without prescription. The additions are in red and the deletions are with strikethrough.

Table 1: Proposed warning statements changes for sedating antihistamines

Medicine/Group/Class	Conditions	Statements or requirements	Required by
Antihistamines, sedating Includes: Alimemazine Brompheniramine Chlorphenamine Cyclizine Dexchlorpheniramine Diphenhydramine Doxylamine Ketotifen Meclozine Mepyramine Pheniramine Promethazine	For oral use	This medicine may cause drowsiness. Be cautious about driving a vehicle or operating machinery within 8 hours of taking this medicine. Do not use in children under 2 years old.	XX/XX/XXXX
	In cough and cold medicines	Do not use in children under 6 years old. Consult a healthcare professional before using in children aged six years and over. Do not use with other antihistamines. Do not use with other medicines intended to treat the symptoms of the common cold except on the advice of a healthcare professional	1/08/2011
	For the treatment of insomnia or anxiety	Do not use in children under 12 years old. Do not exceed the maximum stated dose. This product is for temporary use only. [or] For short term use only. Consult a doctor if sleeplessness (or anxiety) persists.	XX/XX/XXXX

Invitation to comment

Medsafe is seeking comments and input from interested parties on the proposed changes to the labelling requirements for sedating antihistamines that are available without a prescription and a suitable target date for implementation.

Background

At the 166th Medicines Adverse Reactions Committee (MARC) meeting on 29 June 2016, the MARC recommended that Medsafe updates the Label Statements Database to contraindicate the use of sedating antihistamines in children under 2 years of age for all indications and remove ‘anxiety’ as a condition for labelling requirements.

Minutes of the 166th MARC meeting

The MARC also recommended that the Medicines Classification Committee (MCC) consider reclassifying sedating antihistamines to prescription medicines when used in children under 6 years of age for nausea and vomiting, and travel sickness indications. This was considered at the 58th MCC meeting on 16 May 2017, but was not implemented.

Minutes of the 58th MCC meeting

Timetable

Document released for consultation on 2 August 2017.

Interested parties should respond by close of business 29 September 2017.

Feedback will be released following consideration of submissions.

Next steps

Comments are sought on the proposed amendment to the warning statement to be placed on the labels of sedating antihistamines that are available without a prescription. Submissions may address the statement and/or the target date for implementation.

How to respond

Please complete the Medsafe consultation submission form:

Sedating antihistamines label statements consultation submission form (Adobe pdf document, 3 pages, 52 KB)

Sedating antihistamines label statements consultation submission form (Microsoft Word document, 3 pages 34 KB)

Submissions must include full personal or organisational contact details (including address, telephone number or email address).

Electronic submissions are preferred and should be emailed to medsafeapplications@health.govt.nz, and include 'Sedating antihistamine warning statements' in the subject line of the email.

Alternatively, hard copy submissions may be posted to:

Product Regulation
Medsafe
PO Box 5013
Wellington 6140

What will happen

Submissions will be reviewed by Medsafe and feedback on submissions will be provided through the Medsafe website. Input from submitters on the consultation draft will help inform the wording of the statements for sedating antihistamines that are available without a prescription.

Confidentiality

All submissions may be placed on the Medsafe website unless marked confidential. Any confidential material contained within your submission should be clearly marked 'IN CONFIDENCE'. Reasons for a claim of confidentiality must be included in the space provided on the submission coversheet. These reasons must meet Official Information Act 1982 requirements if the submission (or part thereof) is not to be displayed.

The Official Information Act criteria is available here.

For submissions made by individuals, all personal details other than your name will be removed from your submission before it is published on the Medsafe website. In addition, a list of parties making submissions may be published.

If you do not wish to be identified with your submission, or if you do not wish your submission to be associated with a party, you must specifically request this in the space provided on the submission coversheet.

Enquiries

Any questions relating to submissions should be directed by email to medsafeapplications@health.govt.nz