Safety Information

Trans-Tasman Early Warning System - Alert Communication

Vit.D3 – important information for patients with a peanut or soya allergy

Products Affected
Information for consumers and caregivers
Information for healthcare professionals
What actions are Medsafe taking?
How to report adverse events
Further information

Description

This safety concern is being highlighted due to the change in the funding of a colecalciferol-containing product.

The previously funded product Cal-D-Forte tablets had provisional approval for distribution, which expired on 12 February 2016. PHARMAC switched funding to Vit.D3 capsules to ensure a high strength colecalciferol product will continue to be available in New Zealand.

Vit.D3 contains soya oil inside the capsule. Some people are allergic to soya oil and some people with peanut allergy also react to soya oil. This product should not be used by people who are allergic to peanut or soya.

Products Affected

Vit.D3 (colecalciferol) soft gelatin capsule.

Information for consumers and caregivers

Some medicines contain soya oil, which might cause an allergic reaction in patients with a peanut or soya allergy.
Vit.D3 is now being funded in New Zealand. This is a prescription only product. Vit.D3 contains soya oil.
If you have a peanut or soya allergy, please ensure that your doctor or pharmacist are aware of this and ask them to check your medicines.

Information for healthcare professionals

Vit.D3 capsules containing colecalciferol also contain soya oil. This product is contraindicated in patients allergic to peanut or soya.
Please ask patients if they have a peanut or soya allergy before prescribing or dispensing Vit.D3.
No stock of Cal-D-Forte (vitamin D) remains in New Zealand.

What actions are Medsafe taking?

Healthcare professionals and consumers are reminded that the funded medicine containing colecalciferol has changed from Cal-D-Forte to Vit.D3 and Vit.D3 contains soya oil.

How to report adverse events

Phone	+ 64 3 479 7247 to speak to a Medical Assessor at the Centre for Adverse Reactions Monitoring (CARM) From your iPhone using the ADR online app
Online	Submit a report to CARM Prescribers can submit using the online reporting tool available in patient management software
Yellow Card	A completed Yellow card can be submitted to CARM via email, fax or mail
Email	carmnz@otago.ac.nz
Fax	+64 3 479 7150

Medsafe cannot give advice about an individual’s medical condition. If you have any concerns about a medicine you are taking Medsafe encourages you to talk to your healthcare professional.