ADR that result in revision of patient information
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| Singapore: Rhinathiol Promethazine – Restriction of oral formulation use in children less than 6 years of age for safety reasons |
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Health Sciences Authority (HSA) announces that a Dear Healthcare Professional Letter has been issued by Opella Healthcare Singapore Pte. Ltd. to inform healthcare professionals about restrictions in the use of Rhinathiol Promethazine oral formulation in children less than 6 years of age due to safety reasons. The product information has been updated to reflect these restrictions, with amendments made in the sections regarding indication, posology, undesirable effects and warnings / precautions. Healthcare professionals are advised to refer to the updated product information.
The product is used for the alleviation of unproductive and irritative coughs in adults and children aged 6 years and above, particularly when coughing occurs at night.
Please refer to the following website in HSA for details:
http://www.hsa.gov.sg/announcements/dear-healthcare-professional-letter/rhinathiol-promethazine---restriction-of-oral-formulation-use-in-children-less-than-6-years-of-age-for-safety-reasons
In Hong Kong, there are 236 registered oral pharmaceutical products containing promethazine. So far, the Department of Health (DH) has not received any adverse drug reaction report with regard to the use of promethazine in children less than 6 years of age. Related news on restriction of use of cough and cold medicines in children under 6 years of age was previously issued by various overseas drug regulatory authorities, and was posted on the Drug Office website since 21 Jul 2011, with the latest update posted on 13 Jul 2022. Letters to inform local healthcare professionals were issued by DH on 21 Jul 2011 and 13 Jul 2022. In Apr 2009, the Registration Committee of the Pharmacy and Poisons Board of Hong Kong decided that the sales pack label and/or package insert of over-the-counter cough and cold medicines should not contain dosage instructions for children under 6 years of age.
Related news on restriction of use and the risk of psychiatric and central nervous system side effects associated with oral promethazine in children under 6 years of age was previously issued by Australian Therapeutic Goods Administration, and was posted on the Drug Office website on 20 Nov 2024. Letters to inform local healthcare professionals were issued by DH on the same date. As previously reported, the matter will be discussed by the Registration Committee of the Pharmacy and Poisons Board of Hong Kong.
Ends/Thursday, Feb 12, 2026
Issued at HKT 16:45
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