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Through the consultation process, the TGA is requesting comments that will help ensure that the wording of the proposed advisory statements is appropriate and supports the quality use of the medicines; and that the label changes that would be required for these medicines are made in the most convenient, efficient and cost-effective way.
The following first-generation sedating antihistamines are included in Schedule 2 and/or Schedule 3 of the SUSMP (OTC medicines), subject to the requirement that they are not for treatment of children under 2 years of age: recent TGA Medicines Safety Update (MSU), Volume 9, No.However, the enhanced access and availability of OTC medicines means that consumers may not always receive comprehensive advice from a practitioner or pharmacist.In the context of self-medication, the medicine label is the primary source of information for the consumer; so the label must contain the directions and advisory statements that are needed for safe and effective use of these medicines.Invitation to comment | Consultation documents | Timetable | About the consultation | Background | Proposed additional RASML statements - Background | Proposed editorial changes | Proposed changes (with change-tracking) | Content of submissions | Enquiries | What will happen | Privacy information | More information The TGA sought comments from interested parties on the wording of additional advisory statements for first-generation sedating antihistamines for oral use, for inclusion in the Required Advisory Statements for Medicine Labels (RASML) document.The additional RASML advisory statements were proposed in order to ensure that health professionals, parents and carers were adequately cautioned against the use of first-generation sedating antihistamines in children, and particularly in children aged under 2 years of age.
The RASML sets out the advisory statements that are required to be included on the labels of specified medicines. The RASML permits the wording of the actual statements that are included on medicine labels to differ from the wording set out in the RASML, as long as the intent is the same.