Varenicline

There is no significant difference between the old Champix Summary of Product Characteristics (SPC) and the ones for generic varenicline.

Thanks to Kevin Irvine from Boots Digital Health for pointing out these small but important differences from the Champix SPC:
1. A gradual approach to quitting smoking with Varenicline should be considered for patients who are not able or willing to quit abruptly. Patients should reduce smoking during the first 12 weeks of treatment and quit by the end of that treatment period.

2. For patients who have successfully stopped smoking at the end of 12 weeks, an additional course of 12 weeks treatment with Varenicline at 1 mg twice daily may be considered for the maintenance of abstinence. Patients should then continue taking Varenicline for an additional 12 weeks for a total of 24 weeks of treatment.

The full Summary of Product Characteristics (SPC) for the Brown & Burke and Wave Pharma versions of varenicline are below. The SPC are where you can find all the information on usage, side effects, and drug interactions of varenicline - and they are essential reading.

The NHS Specialist Pharmacy Services (SPS) has developed a Patient Group Direction (PGD) as a template for you to develop your own local PGD.

This link will take you to the Specialist Pharmacy Services PGD page so that, if the PGD is ever updated, you will have the most up to date version: Varenicline for smoking cessation – SPS - Specialist Pharmacy Service – The first stop for professional medicines advice

Despite the evidence on safety and efficacy, getting some local medicines management and prescribers to accept varenicline as an equal first-line treatment option was in some cases difficult.

This briefing published in 2013 was intended as a resource for commissioners, managers and staff of stop smoking services and is set out as answers to a series of questions.

This document was written about, and based upon evidence from research investigating, Champix. Generic versions of varenicline are now available and the evidence in this briefing, and the conclusions drawn, are equally applicable to generic varenicline.

When Champix was first available in the UK in 2006, there was reporting on the incidence of cardiovascular serious adverse events among those using varenicline and a call to evaluate the association of cardiovascular serious adverse events with the use of varenicline.

Two meta-analyses have reviewed existing evidence. Whilst findings were not uniform, based on the findings of these reviews, the risk of cardiovascular events associated with the use of varenicline is judged to be minimal and clinically insignificant.

This document was written in 2013 about, and based upon evidence from research investigating, Champix. Generic versions of varenicline are now available and the evidence in this briefing, and the conclusions drawn, are equally applicable to generic varenicline.

Note: The recent changes to the service product characteristics (SPC) for varenicline do not substantially change the points raised in this briefing nor the advice that it is safe and effective.