Product Notification

HPS Pharmacies wish to give notice of a potential labelling issue with Zincaps as below:

Zincaps Capsules
Zinc (as zinc sulfate monohydrate) 50mg
ARTG 27995


Zincaps® contain zinc sulfate monohydrate 137.4mg which is equivalent to 50mg elemental zinc. The image on the left displays the old packaging with the correct labelling. The image on the right is the new labelling which incorrectly states that each capsule contains zinc sulphate 50mg before continuing to state the correct information. The sponsor has been alerted to this issue and we are awaiting their recommendations on further action.

To avoid potential toxicity, it is essential that the correct dose of the correct salt form is administered. Prescribing zinc as the dosage of elemental zinc may improve the clarity of orders. Alternatively, prescribing by brand name and the number of capsules or tablets per dose may prevent errors from occurring. Acute effects from ingesting high doses of zinc can include nausea, vomiting, anorexia, abdominal cramps, diarrhoea, and headache. Ingesting high doses of zinc over prolonged periods can interfere with copper metabolism and result in nerve damage.

There are a number of ways that zinc can be expressed which can cause confusion. The following table demonstrates the equivalence of various salts of zinc in terms of their elemental zinc content.

Zinc salt Amount ≈ 50mg elemental zinc
Zinc chloride 103.92mg
Zinc citrate 146mg
Zinc gluconate 385mg
Zinc sulfate monohydrate 137.4mg
Zinc sulfate heptahydrate 220mg

Retain this notice in a prominent position, including in other related business units for one month. Report any problems identified with medicines, vaccines or medical devices to the TGA.

Should you require further information regarding this matter, please contact your pharmacist at HPS Pharmacies.

References:

National Institutes of Health. Zinc fact sheet for health professionals. US Department of Health and Human Services, 2018.

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