Products found to contain undeclared medicines
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| Australia: Safety advisory: Germany Niubian tablets contain the undeclared substance sildenafil |
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The Therapeutic Goods Administration (TGA) has tested a product labelled Germany Niubian tablets and found that the tablets contain the undeclared substance sildenafil. Sildenafil may interact with nitrates found in some prescription drugs and may lower blood pressure to dangerous levels. People with diabetes, high blood pressure, high cholesterol or heart disease are often prescribed nitrates. Sildenafil taken in combination with other medications can cause serious side effects.
Consumers are advised that sildenafil is a prescription-only substance in Australia.
The supply of Germany Niubian tablets containing undisclosed sildenafil is illegal. Germany Niubian tablets have not been assessed by the TGA for quality, safety or efficacy as required under Australian legislation, and the place of manufacture is not approved by the TGA.
Consumers should stop using Germany Niubian tablets and take any remaining tablets to their local pharmacy for safe disposal. If they have used any of the product and have concerns, consult their health care practitioner.
Please refer to the following website in TGA for details:
http://www.tga.gov.au/news/safety-alerts/germany-niubian-tablets-0
In Hong Kong, the above product is not a registered pharmaceutical product. Related news was previously issued by United States Food and Drug Administration and TGA, and was posted on the Drug Office website on 2 Mar 2015 and 23 Aug 2018.
Ends/Thursday, Jun 8, 2023
Issued at HKT 14:00
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