Rhinathiol 2% (carbocisteine) Children and Infant Syrup - Contraindication in children below 2 years old

Sanofi-Aventis Singapore Pte Ltd is informing healthcare professionals that they will be adopting the French authorities' decision to contraindicate the use of Rhinathiol 2% Children and Infant syrup in children below 2 years of age. This decision arose from the French Regulatory Agency's (Afssaps) evaluation of pharmacovigilance data which indicated the risk of aggravation of respiratory symptoms in connection with the use of mucolytic products to treat bronchial secretion in children below 2 years old. This led the French authorities to conclude that the benefit risk ratio of mucolytic products in children less than 2 years of age is no longer favourable and the contraindication of these products in this group of children is required as a precautionary measure. The local package insert for Rhinathiol 2% Children and Infant syrup will be updated to reflect this new contraindication. The packaging will subsequently be changed and renamed as Rhinathiol 2% Children Syrup. The new packaging with the revised package insert is estimated to be implemented in Singapore in February 2011.

Only abstracts of the Dear Healthcare Professional Letters (DHCPL) are provided on this website. Details of these letters can be found in the MOH Alert System, which is accessible via the Health Professionals Portal (HPP), a one-stop portal for all healthcare professionals in Singapore. Dentists, medical doctors and pharmacists may access HPP at https://hpp.moh.gov.sg and follow the procedures below to access the MOH Alert system.

Step 1: Select your profession under ‘For Healthcare Professionals’.

Step 2: Click on ‘Useful links’.

Step 3: Click on ‘MOH Alert’ and log in via Singpass.

Step 4: Click on ‘Drug Alerts’ or ‘Med Device Alerts’ to view the DHCPLs.