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Safety Information

Published: 7 November 2014

Early Warning System - Monitoring Communication

Medsafe emphasises that patients should NOT stop using any medicine or medical device subject to a monitoring communication. If you have any concerns with a medicine or medical device you are using, please contact your health professional. A monitoring communication does not mean that the medicine or medical device causes an adverse event.

Ethics Enalapril 5mg tablets - Difficulty in halving tablets

7 November 2014

Medsafe has been informed that some patients may be experiencing difficulty halving Ethics Enalapril 5mg tablets.

Ethics Enalapril tablets are indicated for various medical conditions in New Zealand. The approved dosage regimen includes a 2.5mg dose for some patients. This dose can only be obtained by a patient if he/she is able to accurately halve the 5mg tablet.

Although the various strengths of Ethics Enalapril tablets have a break line, which indicates that the tablets have been tested and shown to break evenly and provide an accurate half tablet dose, Medsafe is concerned that some patients are unable to halve these tablets and so are unable to obtain the correct dose of their medication.

Products Affected

Ethics Enalapril 5mg tablets

Regulator Actions

Medsafe is continuing to monitor reports relating to Ethics Enalapril tablets.

Additional Information

Please find a link to the New Zealand Data Sheet below.
http://www.medsafe.govt.nz/profs/Datasheet/e/EthicsEnalapriltab.pdf

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