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TGA issues Warning on Soft Gel Capsules

By Petrina Smith
Thursday, 20 February, 2014


The Therapeutic Goods Administration has issued a warning to health professionals and consumers advising that medicines that come in the form of soft gel capsules may pose a choking risk for children, especially those aged under five years.
Soft gel capsules are typically a gelatine-based shell, containing a liquid. They can be used as a dosage form for a variety of medicines, including complementary medicines, such as vitamins.  In some cases, these medicines may have directions for use that say that they can or should be chewed. Even when chewed, soft gel capsules may pose a choking risk for children.
The TGA has published information for sponsors and potential sponsors of medicines supplied in the form of soft gel capsules marketed for children, advising them to restrict the use of those products to children aged 5 years or older.
For further information for health professionals, consumers and sponsors, please go to www.tga.gov.au/safety/alerts-medicine-soft-gel-capsules-140219.htm#.UwVRkLBWHct

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