Guidelines and Codes
Labelling of Non-Sedating Antihistamines
Added to web site: September 2003
The grace period for companies with product in non-compliant labelling lapsed on 1 April 2003. Medsafe again wishes to remind Companies marketing non-sedating antihistamines of the legislative requirement (Regulation 22 (1) of the Medicines Regulations 1984) to include a warning statement on the product label regarding the potential for sedation with these products.
The modified warning recommended by the Medicines Adverse Reactions Committee and printed in the New Zealand Regulatory Guidelines for Medicines Volume 1, 5th Edition may be used. For information, this section is reproduced below.
NZRGM Volume 1: Section 12.10.2 Antihistamines
Regulation 22 of the Medicines Regulations 1984 requires antihistamines to be
labelled with a warning:
“Be cautious about driving a vehicle or operating machinery within 8 hours of taking this medicine.”
The same regulation also provides for the Director-General of Health to grant an exemption from this requirement. Non-sedating (“second generation”) antihistamines, while not having a sedating effect on most people, may still have a sedating effect on some individuals, and are required to carry the following warning on their labels:
“Although the medicine is unlikely to affect your ability to drive or operate machinery, a few people may be impaired and care should be taken.”