ZANTAC 150mg and ZANTAC Double Strength 300mg tablets will soon be available again in major Australian pharmacy and grocery outlets following reinstatement on the Australian Register of Therapeutic Goods.
ZANTAC is a histamine-2 receptor antagonist over-the-counter (OTC) medicine for the treatment of gastro-oesophageal reflux symptoms such as heartburn and acid indigestion.
In September 2019, the Therapeutic Goods Administration removed all medicines containing ranitidine from the Australian market over concerns about the level of nitrosamine impurities in ranitidine products, specifically N-Nitrosodimethylamine (NDMA).
To be included on the ARTG, the TGA evaluates all registered medicines for safety and efficacy. Aspen Pharmacare Australia, the sponsor of ZANTAC tablets, has worked with the TGA to demonstrate that ZANTAC is stable throughout its shelf life and that nitrosamines are controlled within internationally established acceptable intake limits applied to the maximum daily dose, ensuring all requirements are met for the inclusion of ZANTAC as a registered medicine on the ARTG.
“As one of Australia’s largest pharmaceutical companies, Aspen is committed to delivering products that healthcare professionals can confidently recommend to their patients and customers,” says Aspen Pharmacare Australia Head of Consumer OTC Alison Holland.
“Aspen is pleased that ZANTAC has been reinstated on the ARTG. We’ve worked closely with the TGA and feel that this is a positive development for healthcare professionals, as it provides more options for their patients seeking relief from heartburn and acid indigestion.”
ZANTAC 150mg tablets are indicated for effective 12-hour relief and ZANTAC Double Strength 300mg tablets for 24-hour relief from heartburn and acid indigestion due to gastro-oesophageal reflux.
ZANTAC 150mg and ZANTAC Double Strength 300mg tablets is available from major pharmacy and grocery outlets nationally, without a prescription.
Always read the label and follow the directions for use.
